2 Herpesvirus Hominis 1 CF Antigen,2 Herpesvirus Hominis 1 Cf Antisera Suppliers & Manufacturers

1 to 50 of 447 results  Page: [1] 2 3 4 5 6 7 8 9 >> Next 50 Results
2 Herpesvirus Hominis 1 CF Antigen (FDA Code: GQN / 866.3305)
Remel, Mardx Diagnostics, Inc., Diagnostic Hybrids, more...

2 Herpesvirus Hominis 1 Cf Antisera (FDA Code: GQO / 866.3305)
Diagnostic Automation, Inc., Innominata dba GenBio, Hemagen Diagnostics, Inc., more...

2 Herpesvirus Hominis 1 Fluorescent Antisera (FDA Code: GQL / 866.3305)
Diagnostic Automation, Inc., Bio-Rad Laboratories, Inc., Remel, more...

A/H5 Ns1 Protein Novel Influenza A Virus (FDA Code: OMS / 866.3332)
Arbor Vita Corporation

Acoustic Scanning Laser Microscope
Jeol (UK) Ltd., Nikon Canada Inc., Instrument Div.

Acrylic Glove Box Holders
Cleatech LLC, Heathrow Scientificr LLC, The Baker Company, more...

Adenovirus 1-33 CF Antigen (FDA Code: GOD / 866.302)

Identification. Adenovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to adenovirus in serum. Additionally, some of these reagents consist of adenovirus antisera conjugated with a fluorescent dye and are used to identify adenoviruses directly from clinical specimens. The identification aids in the diagnosis of disease caused by adenoviruses and provides epidemiological information on these diseases. Adenovirus infections may cause pharyngitis (inflammation of the throat), acute respiratory diseases, and certain external diseases of the eye (e.g., conjunctivitis).

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 866.9.

DRG International, Inc., SA Scientific, Inc., Mardx Diagnostics, Inc., more...

Adenovirus 1-33 CF Antisera (FDA Code: GOA / 866.302)

Identification. Adenovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to adenovirus in serum. Additionally, some of these reagents consist of adenovirus antisera conjugated with a fluorescent dye and are used to identify adenoviruses directly from clinical specimens. The identification aids in the diagnosis of disease caused by adenoviruses and provides epidemiological information on these diseases. Adenovirus infections may cause pharyngitis (inflammation of the throat), acute respiratory diseases, and certain external diseases of the eye (e.g., conjunctivitis).

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 866.9.

Genzyme Biosurgery, Mardx Diagnostics, Inc., Centers for Disease Control and Prevention, more...

Adenovirus 1-33 HA Antigen (FDA Code: GOB / 866.302)

Identification. Adenovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to adenovirus in serum. Additionally, some of these reagents consist of adenovirus antisera conjugated with a fluorescent dye and are used to identify adenoviruses directly from clinical specimens. The identification aids in the diagnosis of disease caused by adenoviruses and provides epidemiological information on these diseases. Adenovirus infections may cause pharyngitis (inflammation of the throat), acute respiratory diseases, and certain external diseases of the eye (e.g., conjunctivitis).

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 866.9.

Trinity Biotech Plc

Adenovirus 1-33 Neutralization Antisera (FDA Code: GNZ / 866.302)

Identification. Adenovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to adenovirus in serum. Additionally, some of these reagents consist of adenovirus antisera conjugated with a fluorescent dye and are used to identify adenoviruses directly from clinical specimens. The identification aids in the diagnosis of disease caused by adenoviruses and provides epidemiological information on these diseases. Adenovirus infections may cause pharyngitis (inflammation of the throat), acute respiratory diseases, and certain external diseases of the eye (e.g., conjunctivitis).

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 866.9.

Centers for Disease Control and Prevention, Alfa Biotech Spa

Aerobic Incubator
Stratagene, Yamato Scientific America Inc., Fisher Scientific International, Inc., more...

Aerobic Transport System (FDA Code: JTW / 866.29)

Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

Classification. Class I (general controls).

Copan Diagnostics Inc., Gen-probe Incorporated, Becton, Dickson & Co.,, more...

Agar Plate Test
Becton, Dickson & Co.,, New Brunswick Scientific Co., Inc., PML Microbiologicals, Inc., more...

Agar Tube Test
Becton, Dickson & Co.,, PML Microbiologicals, Inc., Organon Teknika B.V.

Alzheimer's Dementia Test
Innogenetics Nv

Amino Acid Analyzer
Applied Biosystems, Bio-Rad Laboratories, Inc., Varian, Inc., more...

Amino Acid Analyzer Reagent
Bio-Rad Laboratories, Inc., Siemens Healthcare Diagnostics, Beckman Coulter, Inc., more...

Amino Acid Assay Culture Media (FDA Code: JRZ / 866.235)

Identification. A microbiological assay culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate selected test microorganisms in order to measure by microbiological procedures the concentration in a patient's serum of certain substances, such as amino acids, antimicrobial agents, and vitamins. The concentration of these substances is measured by their ability to promote or inhibit the growth of the test organism in the innoculated medium. Test results aid in the diagnosis of disease resulting from either deficient or excessive amounts of these substances in a patient's serum. Tests results may also be used to monitor the effects of the administration of certain antimicrobial drugs.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 866.9.

Becton, Dickson & Co.,, Gemini Bio-Products, Inc., Alpha Biosciences, Inc., more...

Anaerobic Chamber
Almore International Inc., Coy Laboratory Products, Inc., Sheldon Mfg., Inc.

Anaerobic Glove Box (FDA Code: JTM / 866.212)

Identification. An anaerobic chamber is a device intended for medical purposes to maintain an anaerobic (oxygen free) environment. It is used to isolate and cultivate anaerobic microorganisms.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 866.9. The device is also exempt from the 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.

Airgas Gaspro Inc., The Baker Company, Nuaire, Inc., more...

Anaerobic Identification Kit Test (FDA Code: JSP / 866.266)

Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 866.9.

Siemens Healthcare Diagnostics, Remel, Becton, Dickson & Co.,, more...

Anaerobic Incubator
Billups-Rothenberg, Inc., Thermo Fisher Scientific Inc, Fisher Scientific International, Inc., more...

Anaerobic Transport Culture Media (FDA Code: JSL / 866.239)

Identification. A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

Classification. Class I (general controls).

Copan Diagnostics Inc., Remel, Becton, Dickson & Co.,, more...

Anaerobic Transport System (FDA Code: JTX / 866.29)

Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

Classification. Class I (general controls).

Copan Diagnostics Inc., Becton, Dickson & Co.,, Tulip Medical Products, more...

Animal Cage
Fisher Scientific International, Inc., Nalge Nunc International, Carolina Biological Supply Company, more...

Anti-Streptokinase Test (FDA Code: GTO / 866.372)
Immunostics, Inc., Triangle Biomedical Sciences, Inc., Regimed Medical, more...

Antibiotic Assay Culture Media (FDA Code: JSA / 866.235)

Identification. A microbiological assay culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate selected test microorganisms in order to measure by microbiological procedures the concentration in a patient's serum of certain substances, such as amino acids, antimicrobial agents, and vitamins. The concentration of these substances is measured by their ability to promote or inhibit the growth of the test organism in the innoculated medium. Test results aid in the diagnosis of disease resulting from either deficient or excessive amounts of these substances in a patient's serum. Tests results may also be used to monitor the effects of the administration of certain antimicrobial drugs.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 866.9.

Pedinol Pharmacal, Inc., Becton, Dickson & Co.,, Biosource International, Inc.,, more...

Antibiotic Sensitivity Disc Dispenser
Fisher Scientific International, Inc., Becton, Dickson & Co.,, Culture Kits, Inc., more...

Antibiotic Susceptibility Test
Quidel Corporation, Giles Scientific, Inc., Microtech Medical Systems, more...

Antibody Detection Candida Species (FDA Code: LSG / 866.3165)
Genzyme Biosurgery, AT First Diagnostic Ltd, SA Scientific, Inc., more...

Antifungal Susceptibility Test Plate (FDA Code: NGZ / 866.164)

Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

Classification. Class II (performance standards).

Accumed International Ltd., Biomerieux Italy

Antimicrobial Drug Removal Device (FDA Code: LJF / 866.256)

Identification. A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

Classification. Class I. With the exception of automated blood culturing system devices that are used in testing for bacteria, fungi, and other microorganisms in blood and other normally sterile body fluids, this device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

Superex Canada Ltd

Antimicrobial Solution (FDA Code: LOP / 866.164)

Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

Classification. Class II (performance standards).

Woodward Laboratories, Inc, Aplicare, Inc, Barrier Technologies Inc., more...

Antimicrobial Susceptibility Test Cards (FDA Code: LTW / 866.164)

Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

Classification. Class II (performance standards).

Siemens Healthcare Diagnostics, Microtech Medical Systems, Biomerieux Italy

Antimicrobial Susceptibility Test Culture Media (FDA Code: JSO / 866.17)

Identification. A culture medium for antimicrobial susceptibility tests is a device intended for medical purposes that consists of any medium capable of supporting the growth of many of the bacterial pathogens that are subject to antimicrobial susceptibility tests. The medium should be free of components known to be antagonistic to the common agents for which susceptibility tests are performed in the treatment of disease.

Classification. Class II (performance standards).

Remel, Becton, Dickson & Co.,, EMD Chemicals, Inc., more...

Antimicrobial Susceptibility Test Disc (FDA Code: JTN / 866.162)

Identification. An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

Classification. Class II (performance standards).

Becton, Dickson & Co.,, Hardy Diagnostics, Eli Lilly & Co., more...

Antimicrobial Susceptibility Test Panels (FDA Code: LTT / 866.164)

Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

Classification. Class II (performance standards).

Siemens Healthcare Diagnostics, Trek Diagnostic Systems, Inc.

Antimicrobial Susceptibility Test Powder (FDA Code: JTT / 866.164)

Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

Classification. Class II (performance standards).

Becton, Dickson & Co.,, Statens Serum Institut

Antimycobacterial Susceptibility Test Powders (FDA Code: MJA / 866.164)

Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

Classification. Class II (performance standards).

Becton, Dickson & Co.,, Trek Diagnostic Systems, Inc., Accumed International Ltd.

Antisera, Control for Non-Treponemal Test (FDA Code: GMP / 866.382)
Remel, New Horizons Diagnostics Corporation, Fisher Scientific International, Inc., more...

Antistreptolysin-Titer/Streptolysin O Reagent (FDA Code: GTQ / 866.372)
Siemens Healthcare Diagnostics, Remel, Thermo Fisher Scientific Inc, more...

Arizona Spp Antiserum (FDA Code: GTE / 866.3035)
Centers for Disease Control and Prevention, Equitech-bio Inc

Aspergillus Spp CF Antigen (FDA Code: JWT / 866.304)
DRG International, Inc., Biodesign International, Immuno-mycologies Inc, more...

Aspergillus Spp. Galactomannan Antigen (FDA Code: NOM / 866.304)
Adil Instruments

Aspergillus Spp. Positive Control Antiserum (FDA Code: KFG / 866.304)
Biodesign International, Immuno-mycologies Inc

Auto reader & Interpretation of Overnight Susceptiblity Systems (FDA Code: LRG / 866.164)

Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

Classification. Class II (performance standards).

Siemens Healthcare Diagnostics, Trek Diagnostic Systems, Inc., Accumed International Ltd.

Auto Reader of Overnight Microorganism Identification System (FDA Code: LRH / 866.266)

Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 866.9.

Siemens Healthcare Diagnostics, Becton, Dickson & Co.,, Accumed International Ltd., more...

Automated Antimicrobial Susceptibility Test System (FDA Code: LON / 866.1645)

Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.

Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA."

Siemens Healthcare Diagnostics, Becton, Dickson & Co.,, Trek Diagnostic Systems, Inc., more...

Automated Colony Counter (FDA Code: KZB / 866.217)

Identification. An automated colony counter is a mechanical device intended for medical purposes to determine the number of bacterial colonies present on a bacteriological culture medium contained in a petri plate. The number of colonies counted is used in the diagnosis of disease as a measure of the degree of bacterial infection.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 866.9.

Advanced Instruments, Inc., American Bantex, Corp., Interscience

Automated Zone Reader (FDA Code: KZK / 866.285)

Identification. An automated zone reader is a mechanical device intended for medical purposes to measure zone diameters of microbial growth inhibition (or exhibition), such as those observed on the surface of certain culture media used in disc-agar diffusion antimicrobial susceptibility tests. The device aids in decisionmaking respecting the treatment of disease.

Classification. Class I (general controls).

Giles Scientific, Inc.

1 to 50 of 447 results  Page: [1] 2 3 4 5 6 7 8 9 >> Next 50 Results
Browse Category   |   Alphabetical Products   |   ALL 25,000 Suppliers
HomeBuyAdd FREE ListingAdvertise Medical CompanyMedical Portal