Acid Containing Decalcifier Pathology Solution,Acid Containing Fixative Suppliers & Manufacturers

1 to 50 of 273 results  Page: [1] 2 3 4 5 6 >> Next 50 Results
Acid Containing Decalcifier Pathology Solution (FDA Code: KDX / 864.401)
Remel, Richard-Allan Scientific, SIGMA-ALDRICH CORP, more...

Acid Containing Fixative (FDA Code: LDW / 864.401)
Ventana Medical Systems, Inc., Remel, Richard-Allan Scientific, more...

Acid Fuchsin Stain (FDA Code: IDF / 864.185)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

SIGMA-ALDRICH CORP, Fisher Scientific International, Inc., Becton, Dickson & Co.,, more...

Acridine Orange Stain (FDA Code: IDC / 864.185)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Fisher Scientific International, Inc., Becton, Dickson & Co.,, EMD Chemicals, Inc., more...

Albumin Based Adhesive (FDA Code: KEL / 864.401)
EMD Chemicals, Inc., American Mastertech Scientific, Inc., Medical Chemical Corporation, more...

Alcian Blue Stain (FDA Code: IDA / 864.185)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Ventana Medical Systems, Inc., Remel, Fisher Scientific International, Inc., more...

Alcohol Containing Fixative (FDA Code: LDZ / 864.401)
Ventana Medical Systems, Inc., Monogen, Remel, more...

Aldehyde Fuchsin Stain (FDA Code: IDB / 864.185)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

EMD Chemicals, Inc., American Mastertech Scientific, Inc., Rowley Biochemical Inc., more...

Alizarin Red Stain (FDA Code: IDD / 864.185)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Fisher Scientific International, Inc., EMD Chemicals, Inc., American Mastertech Scientific, Inc., more...

Alpha-Fetoprotein Test
Siemens Healthcare Diagnostics, Dako North America, Inc., Alfigen, The Genetics Institute, more...

Ammoniacal Silver Hydroxide Silver Nitrate Stain (FDA Code: ICZ / 864.185)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Ventana Medical Systems, Inc., Dako North America, Inc., American Mastertech Scientific, Inc., more...

Aniline (FDA Code: ICX / 864.185)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Rowley Biochemical Inc., Rocket Medical

Aniline Acid Fuchsin (FDA Code: ICY / 864.185)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

American Mastertech Scientific, Inc., Rowley Biochemical Inc.

Aniline Blue Stain (FDA Code: KFD / 864.185)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Remel, Richard-Allan Scientific, SIGMA-ALDRICH CORP, more...

Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells Immunohistochemical Reagent (FDA Code: NTR / 864.186)

Identification. Immunohistochemistry test systems (IHC's) are in vitro diagnostic devices consisting of polyclonal or monoclonal antibodies labeled with directions for use and performance claims, which may be packaged with ancillary reagents in kits. Their intended use is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similar devices intended for use with flow cytometry devices are not considered IHC's.

Spring Bioscience

Auramine O Stain (FDA Code: KJK / 864.185)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Becton, Dickson & Co.,, Medical Chemical Corporation, Mallinckrodt Baker, Inc., more...

Automated Cervical Cytology Slide Reader (FDA Code: MNM)
Hologic Inc, Becton, Dickson & Co.,, BD Diagnostics - TriPath

Automated Chromosome Analyzer (FDA Code: LNJ / 864.526)

Identification. An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)

Classification. Class II (performance standards).

Biosource International, Applied Imaging Corp., Hybaid Limited, more...

Automated Cytology Slide Processor (FDA Code: MKQ)
Monogen, Hologic Inc, Becton, Dickson & Co.,, more...

Automated Digital Image Manual Interpretation Microscope (FDA Code: OEO / 864.186)

Identification. Immunohistochemistry test systems (IHC's) are in vitro diagnostic devices consisting of polyclonal or monoclonal antibodies labeled with directions for use and performance claims, which may be packaged with ancillary reagents in kits. Their intended use is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similar devices intended for use with flow cytometry devices are not considered IHC's.

Aperio Technologies, Inc.

Automated Tissue Stainer (FDA Code: KEY / 864.38)

Identification. An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.

Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9.

Ventana Medical Systems, Inc., Siemens Healthcare Diagnostics, TED Pella, Inc., more...

Autopsy Glove
Howard Medical Company, CMS Worldwide, Inc., Adaptive Medical Concepts, Inc., more...

Autopsy Saw
Mortech, Manufacturing Inc., Thermo Fisher Scientific Inc, Thermo Fisher Scientific (Asheville) LLC, more...

Autopsy Scale
Mortech, Manufacturing Inc., DRE, Inc., Algen Scale Corp.

Autopsy Station
The Histo-line Laboratories, Funeralia Gmbh, Scientek Technology Corporation

Autopsy/Dissecting Table
Pacific Research Laboratories, Inc., COX Surgical Ltd., Harvard Apparatus, Ltd., more...

Azan Counterstain (FDA Code: ICT / 864.185)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Immco Diagnostics, Rowley Biochemical Inc.

Azocarmine G (FDA Code: ICS / 864.185)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Rowley Biochemical Inc.

Azure A Stain (FDA Code: ICQ / 864.185)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Fisher Scientific International, Inc., EMD Chemicals, Inc.

Balanced Salt Solutions (FDA Code: KIP / 864.2875)

Identification. A balanced salt solution or formulation is a defined mixture of salts and glucose in a simple medium. This device is included as a necessary component of most cell culture systems. This media component controls for pH, osmotic pressure, energy source, and inorganic ions.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9.

Invitrogen Corporation, Clinical Diagnostic Solutions, Inc, SIGMA-ALDRICH CORP, more...

Basic Fuchsin (FDA Code: KKW / 864.185)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Remel, Richard-Allan Scientific, EMD Chemicals, Inc., more...

Basic Fuchsin Counter Stain
Richard-Allan Scientific, Volu-sol, Inc., American Mastertech Scientific, Inc., more...

Best'S Carmine (FDA Code: ICO / 864.185)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Rowley Biochemical Inc.

Biebrich Scarlet Stain (FDA Code: ICN / 864.185)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Remel, Richard-Allan Scientific, SIGMA-ALDRICH CORP, more...

Bismarck Brown Y Stain (FDA Code: KJM / 864.185)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

EMD Chemicals, Inc., American Mastertech Scientific, Inc.

Bouin's Fluid (FDA Code: IGN / 864.401)
Remel, EMD Chemicals, Inc., Labchem Inc., more...

Brilliant Cresyl Blue Stain (FDA Code: KJN / 864.185)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

EMD Chemicals, Inc., Ricca Chemical Company LLC

Brilliant Green Stain (FDA Code: KJO / 864.185)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Becton, Dickson & Co.,, EMD Chemicals, Inc., Volu-sol, Inc., more...

Brilliant Yellow Stain (FDA Code: ICM / 864.185)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Polysciences Inc

C-Kit Immunohistochemistry Antibody Assay (FDA Code: NKF / 864.186)

Identification. Immunohistochemistry test systems (IHC's) are in vitro diagnostic devices consisting of polyclonal or monoclonal antibodies labeled with directions for use and performance claims, which may be packaged with ancillary reagents in kits. Their intended use is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similar devices intended for use with flow cytometry devices are not considered IHC's.

Ventana Medical Systems, Inc., Dako North America, Inc.

Cadaver Dissection Table
Evergreen Orthopedic Research Lab, COX Surgical Ltd., Harvard Apparatus, Ltd., more...

Carbol Fuchsin Stain (FDA Code: ICL / 864.185)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Ventana Medical Systems, Inc., Remel, Richard-Allan Scientific, more...

Carmine Stain (FDA Code: KJP / 864.185)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

American Mastertech Scientific, Inc., Mallinckrodt Baker, Inc., Polysciences Inc

Carnoy's Pathology Solution (FDA Code: IGM / 864.401)
American Mastertech Scientific, Inc., EK Industries, Inc., Ricca Chemical Company LLC, more...

Cell Adhesive Slide
Mercedes Medical, Paul Marienfeld GmbH & Co. KG, CML Consortium De Materiel Pour Lab.

Cell Culture Spinner System (FDA Code: KJE / 864.224)

Identification. Cell and tissue culture supplies and equipment are devices that are used to examine, propagate, nourish, or grow cells and tissue cultures. These include such articles as slide culture chambers, perfusion and roller apparatus, cell culture suspension systems, and tissue culture flasks, disks, tubes, and roller bottles.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. If the devices are not labeled or otherwise represented as sterile, they are exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Wheaton Industries Inc.

Cell Culture Suspension System (FDA Code: KJF / 864.224)

Identification. Cell and tissue culture supplies and equipment are devices that are used to examine, propagate, nourish, or grow cells and tissue cultures. These include such articles as slide culture chambers, perfusion and roller apparatus, cell culture suspension systems, and tissue culture flasks, disks, tubes, and roller bottles.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. If the devices are not labeled or otherwise represented as sterile, they are exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Remel, Nalge Nunc International, North American Science Associates, Inc., more...

Cell Sorter (FDA Code: KEX)
Millipore, Beckman Coulter, Inc., Immunicon Corporation

Celloidin (FDA Code: IEZ / 864.401)
Rowley Biochemical Inc., Mallinckrodt Baker, Inc., Polysciences Inc

Centromere Detector
Antibodies, Inc.

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