Microbiology Diagnostic Device Suppliers
Limit companies to: Worldwide USA
Bowman Hewitt Solutions | Address: , USA 
https://www.bowmanhewittsolutions.com | Send Inquiry | Phone: +1-(864)-361-4120
Products: Diagnostic Devices, Point-of-Care (POC) Diagnostic Devices, Diagnostics Devices, Diathermy, Neurodiagnostic Devices, Microbiology Diagnostic Device (FDA Code: LIB), Invasive Diagnostic Devices, ...
Bowman Hewitt Solutions specializes in providing medical diagnostic devices. Our TM Flow System is a non-invasive medical diagnostic device that is used for testing and monitoring the Automatic Nervou more...
https://www.bowmanhewittsolutions.com | Send Inquiry | Phone: +1-(864)-361-4120
Products: Diagnostic Devices, Point-of-Care (POC) Diagnostic Devices, Diagnostics Devices, Diathermy, Neurodiagnostic Devices, Microbiology Diagnostic Device (FDA Code: LIB), Invasive Diagnostic Devices, ...
Bowman Hewitt Solutions specializes in providing medical diagnostic devices. Our TM Flow System is a non-invasive medical diagnostic device that is used for testing and monitoring the Automatic Nervou more...
Remel | Address: 12076 Santa Fe Drive, P.O. Box 14428, Lenexa, Kansas 66215, USA
www.remelinc.com | Send Inquiry | Phone: +1-(913)-888-0939
FDA Registration: 1031428 Year Established: 1973 Employee Count: ~20
Products: Swabs, Chemical Sterilizers (FDA Code: MLR), Coagulation Analyzers (FDA Code: GKP), Myoglobin (FDA Code: DDR), Sliding Microtomes (FDA Code: KFL), Rotary Microtomes (FDA Code: IDO), ...
Remel offers a wide range of microbiology products that are used in the clinical, industrial, research and academic laboratories. Our products help diagnose infection quickly and accurately, providing more...
www.remelinc.com | Send Inquiry | Phone: +1-(913)-888-0939
FDA Registration: 1031428 Year Established: 1973 Employee Count: ~20
Products: Swabs, Chemical Sterilizers (FDA Code: MLR), Coagulation Analyzers (FDA Code: GKP), Myoglobin (FDA Code: DDR), Sliding Microtomes (FDA Code: KFL), Rotary Microtomes (FDA Code: IDO), ...
Remel offers a wide range of microbiology products that are used in the clinical, industrial, research and academic laboratories. Our products help diagnose infection quickly and accurately, providing more...
Inverness Medical Innovations, Inc. | Address: 51 Sawyer Rd., Suite 200, Waltham, Massachusetts 02453-3448, USA
www.invernessmedical.com | Send Inquiry | Phone: +1-(781)-647-3900
FDA Registration: 3004011380 Year Established: 2005 Annual Revenues: USD 25-50 Million Employee Count: ~180 Quality: CE Certified
Products: Myoglobin (FDA Code: DDR), Ovulation (Luteinizing Hormone) Test Kits, Fertility Monitors, Pregnancy Test Kits, Home pregnancy test kits, Hcg, Influenza A and B Testing rapid Influenza Testing, Automated Urinalysis System (FDA Code: KQO), ...
Inverness Medical Innovations, Inc. manufactures, markets & distributes agents for use in women's health, cardiology and infectious disease. We offer research, development and supply of professional d more...
www.invernessmedical.com | Send Inquiry | Phone: +1-(781)-647-3900
FDA Registration: 3004011380 Year Established: 2005 Annual Revenues: USD 25-50 Million Employee Count: ~180 Quality: CE Certified
Products: Myoglobin (FDA Code: DDR), Ovulation (Luteinizing Hormone) Test Kits, Fertility Monitors, Pregnancy Test Kits, Home pregnancy test kits, Hcg, Influenza A and B Testing rapid Influenza Testing, Automated Urinalysis System (FDA Code: KQO), ...
Inverness Medical Innovations, Inc. manufactures, markets & distributes agents for use in women's health, cardiology and infectious disease. We offer research, development and supply of professional d more...
Hamilton Company | Address: P.O. Box 10030, Reno, Nevada 89520-0012, USA
www.hamiltoncompany.com | Send Inquiry | Phone: +1-(755)-858-3000
Year Established: 1953 Annual Revenues: USD 50-100 Million Employee Count: ~250 Quality: ISO 9001, CE Certified
Products: Fluid Management Systems, Pipette Racks, Medical Needles, Serological Pipette Racks, Manual Pipette Racks, Three Or Four Tier Pipette Racks, ...
Hamilton Company designs and develops manual, semi-automated and robotic products for precision fluid measuring. We are an ISO 9001 & CE MARK certified company. We offer products such as laboratory au more...
www.hamiltoncompany.com | Send Inquiry | Phone: +1-(755)-858-3000
Year Established: 1953 Annual Revenues: USD 50-100 Million Employee Count: ~250 Quality: ISO 9001, CE Certified
Products: Fluid Management Systems, Pipette Racks, Medical Needles, Serological Pipette Racks, Manual Pipette Racks, Three Or Four Tier Pipette Racks, ...
Hamilton Company designs and develops manual, semi-automated and robotic products for precision fluid measuring. We are an ISO 9001 & CE MARK certified company. We offer products such as laboratory au more...
Becton, Dickson & Co., | Address: One Becton Drive, Franklin Lakes, New Jersey 07417, USA
www.bd.com/us | Phone: +1-(201)-847.6800
FDA Registration: 1119779 Annual Revenues: USD 10-25 Million Employee Count: ~1600 Quality: ISO 9000, CE Certified
Products: Anesthesia Equipment, Hypodermic Syringes, Bodyfat Analyzers, Medical Thermometers, Blades, Scalpels, ...
Becton, Dickinson & Co., manufactures and distributes a broad range of medical supplies, devices, laboratory equipment and diagnostic products. Our product BD Soluvia™ is a prefillable microinje more...
www.bd.com/us | Phone: +1-(201)-847.6800
FDA Registration: 1119779 Annual Revenues: USD 10-25 Million Employee Count: ~1600 Quality: ISO 9000, CE Certified
Products: Anesthesia Equipment, Hypodermic Syringes, Bodyfat Analyzers, Medical Thermometers, Blades, Scalpels, ...
Becton, Dickinson & Co., manufactures and distributes a broad range of medical supplies, devices, laboratory equipment and diagnostic products. Our product BD Soluvia™ is a prefillable microinje more...
Wescor Inc. | Address: 370 West 1700 South, Logan, Utah 84321, USA
www.wescor.com | Send Inquiry | Phone: +1-(435)-752-6011, 800- 453-2725
FDA Registration: 1717966 Year Established: 1970 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO, CE Certified
Products: Slide Stainers, General Diagnostic Supplies, Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Automated Slide Stainer (FDA Code: KPA), Programmable Slide Stainers, Hematology Slide Stainer Instruments, ...
Wescor manufactures & markets instrumentation & other products for medicine, science and industry. Our unique vapor pressure and colloid osmometers, automatic slide stainers, cytocentrifuges & diagnos more...
www.wescor.com | Send Inquiry | Phone: +1-(435)-752-6011, 800- 453-2725
FDA Registration: 1717966 Year Established: 1970 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO, CE Certified
Products: Slide Stainers, General Diagnostic Supplies, Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Automated Slide Stainer (FDA Code: KPA), Programmable Slide Stainers, Hematology Slide Stainer Instruments, ...
Wescor manufactures & markets instrumentation & other products for medicine, science and industry. Our unique vapor pressure and colloid osmometers, automatic slide stainers, cytocentrifuges & diagnos more...
Focus Diagnostics, Inc. | Address: 13665 Dulles Technology Drive, Herndon, Virginia 20171-4603, USA
www.focusdx.com | Phone: +1-(703)-480-2500
FDA Registration: 2023365
Products: Publications, HIV Antibody Test Kits, Helicobacter pylori Urease Test Kits, Gastric pH Test Kits, Gastric Occult Blood and Gastric pH Test Kits, Fecal Occult Blood Test Kits, ...
Focus Diagnostics, Inc. develops & markets quality services for rare, unusual and emerging infectious & immunologic diseases. We are an ISO 13485 certified company. We offer products like HerpeSelectr more...
www.focusdx.com | Phone: +1-(703)-480-2500
FDA Registration: 2023365
Products: Publications, HIV Antibody Test Kits, Helicobacter pylori Urease Test Kits, Gastric pH Test Kits, Gastric Occult Blood and Gastric pH Test Kits, Fecal Occult Blood Test Kits, ...
Focus Diagnostics, Inc. develops & markets quality services for rare, unusual and emerging infectious & immunologic diseases. We are an ISO 13485 certified company. We offer products like HerpeSelectr more...
Mardx Diagnostics, Inc. | Address: 5919 Farnsworth Ct., Carlsbad, California 92008, USA
Phone: +1-(760)-929-0500
FDA Registration: 2245544 Annual Revenues: USD 5-10 Million
Products: Coagulation Analyzers (FDA Code: GKP), Lyme Disease (Borrelia) Test Kits, Automated Coagulation Analyzer (FDA Code: GKP), Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Infectious Disease Test Kits, Automated Coagulation Instrument (FDA Code: GKP), ...
Mardx Diagnostics, Inc. is engaged in developing, manufacturing, and marketing of diagnostic products. We offer western blot, IFA, EIA,and ENA IgG marstripe immunostride tests for 6 extractable nuclea more...
Phone: +1-(760)-929-0500
FDA Registration: 2245544 Annual Revenues: USD 5-10 Million
Products: Coagulation Analyzers (FDA Code: GKP), Lyme Disease (Borrelia) Test Kits, Automated Coagulation Analyzer (FDA Code: GKP), Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Infectious Disease Test Kits, Automated Coagulation Instrument (FDA Code: GKP), ...
Mardx Diagnostics, Inc. is engaged in developing, manufacturing, and marketing of diagnostic products. We offer western blot, IFA, EIA,and ENA IgG marstripe immunostride tests for 6 extractable nuclea more...
Parter Medical Products Inc. | Address: 17015 Kingsview Ave., Carson, California 90746, USA
partermedical.com | Send Inquiry | Phone: +1-(310)-327-4417, 800-666-8282
FDA Registration: 2024311 Year Established: 1984 Annual Revenues: USD 5-10 Million Employee Count: ~140 Quality: ISO 9002 Certified
Products: Plastic Vials, Laboratory Plasticware, Petri Dishes, Petri Dishes, Petri Dishes & Nutrient Agar Kit, Petri Dish Spreaders, Petri Dish Dispenser, ...
Parter Medical Products Inc. manufactures single use, plastic, laboratory products for healthcare, medical and pharmaceutical research markets. We offer petri dishes, specimen containers, and 24 hour more...
partermedical.com | Send Inquiry | Phone: +1-(310)-327-4417, 800-666-8282
FDA Registration: 2024311 Year Established: 1984 Annual Revenues: USD 5-10 Million Employee Count: ~140 Quality: ISO 9002 Certified
Products: Plastic Vials, Laboratory Plasticware, Petri Dishes, Petri Dishes, Petri Dishes & Nutrient Agar Kit, Petri Dish Spreaders, Petri Dish Dispenser, ...
Parter Medical Products Inc. manufactures single use, plastic, laboratory products for healthcare, medical and pharmaceutical research markets. We offer petri dishes, specimen containers, and 24 hour more...
HealthLink | Address: 3611 St John's Bluff Rd South, Suite 1, Jacksonville, Florida 32224, USA
www.healthlinkinc.net | Send Inquiry | Phone: +1-(800)-638-2625
FDA Registration: 1059020
Products: Curettes, Hematology Analyzers, Thermometers, Diagnostic Aids, Biopsy Punches (FDA Code: FCI), Blood Analyzer Reagents, ...
HealthLink is a medical manufacturer. We offer a wide range of medical lamps & batteries, stains & reagents and biological indicators. We manufacture a complete line of prepared culture media. This in more...
www.healthlinkinc.net | Send Inquiry | Phone: +1-(800)-638-2625
FDA Registration: 1059020
Products: Curettes, Hematology Analyzers, Thermometers, Diagnostic Aids, Biopsy Punches (FDA Code: FCI), Blood Analyzer Reagents, ...
HealthLink is a medical manufacturer. We offer a wide range of medical lamps & batteries, stains & reagents and biological indicators. We manufacture a complete line of prepared culture media. This in more...
Abbott Laboratories | Address: 100 Abbott Park Road, Abbott Park, Illinois 60064-3500, USA
www.abbott.com | Send Inquiry | Phone: +1-(847)-937-6100
FDA Registration: 1451914 Employee Count: ~5000
Products: Anesthesia Equipment, Phacoemulsification Systems, Capsular Tension Rings, Viscosurgical Devices (Viscoelastics), Powered Surgical Laser Instrument (FDA Code: GEX), Bladder Cancer Tests, ...
Abbott Laboratories is a diversified health care company which discovers, develops, manufactures and markets innovative products & services that span the continuum of care from prevention, diagnosis t more...
www.abbott.com | Send Inquiry | Phone: +1-(847)-937-6100
FDA Registration: 1451914 Employee Count: ~5000
Products: Anesthesia Equipment, Phacoemulsification Systems, Capsular Tension Rings, Viscosurgical Devices (Viscoelastics), Powered Surgical Laser Instrument (FDA Code: GEX), Bladder Cancer Tests, ...
Abbott Laboratories is a diversified health care company which discovers, develops, manufactures and markets innovative products & services that span the continuum of care from prevention, diagnosis t more...
Virotek, L.L.C. | Address: 1481 Mark St, Elk Grove Vlg, Illinois 60089, USA
Phone: +1-(847)-634-4500
Products: Blood Lancets, Disposable Blood Lancet Needles, Blood Lancet Needle (Pen Type), Blood Lancet Needle (Blade Type), Stainless Steel Blood Lancets, Plastic Blood Lancets, ...
Virotek, L.L.C. supplies inoculating loop and safety lancets. more...
Phone: +1-(847)-634-4500
Products: Blood Lancets, Disposable Blood Lancet Needles, Blood Lancet Needle (Pen Type), Blood Lancet Needle (Blade Type), Stainless Steel Blood Lancets, Plastic Blood Lancets, ...
Virotek, L.L.C. supplies inoculating loop and safety lancets. more...
Metabolic Solutions, Inc. | Address: 460 Amherst St., Nashua, New Hampshire 03063-1220, USA
www.metsol.com | Send Inquiry | Phone: +1-(603)-598-6960, 866-302-1998
Year Established: 1990 Annual Revenues: USD 1-5 Million
Products: Urea Breath Test, Microbiology Diagnostic Device (FDA Code: LIB), Breath/Blood Urea Test (FDA Code: MSQ), Gastro-Urology Probe and Director (FDA Code: FGM), Hydrogen Breath Tests, Lactose Intolerance Breath Tests, ...
Metabolic Solutions, Inc. provides healthcare professionals with non-invasive and highly accurate medical diagnostic breath tests. We offer test kits that contain all the components necessary to admin more...
www.metsol.com | Send Inquiry | Phone: +1-(603)-598-6960, 866-302-1998
Year Established: 1990 Annual Revenues: USD 1-5 Million
Products: Urea Breath Test, Microbiology Diagnostic Device (FDA Code: LIB), Breath/Blood Urea Test (FDA Code: MSQ), Gastro-Urology Probe and Director (FDA Code: FGM), Hydrogen Breath Tests, Lactose Intolerance Breath Tests, ...
Metabolic Solutions, Inc. provides healthcare professionals with non-invasive and highly accurate medical diagnostic breath tests. We offer test kits that contain all the components necessary to admin more...
Dawning Technologies Inc | Address: 409 Mason Rd, Fairport, New York 14450, USA
www.dawning.com | Send Inquiry | Phone: +1-(585)-223-6006
Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: CE Certified
Products: Laboratory Information Systems, Laboratory Information Systems (LIS), Software, Clinical Laboratory Information Systems (LIS), Consultant Service, Software Programs, Data Processing Module for Clinical use (FDA Code: JQP), ...
Dawning Technologies Inc focuses on interfacing solutions for clinical laboratories, IVD instruments, information system vendors and pharmaceutical/biotech companies. We produce javalin, jresultnet an more...
www.dawning.com | Send Inquiry | Phone: +1-(585)-223-6006
Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: CE Certified
Products: Laboratory Information Systems, Laboratory Information Systems (LIS), Software, Clinical Laboratory Information Systems (LIS), Consultant Service, Software Programs, Data Processing Module for Clinical use (FDA Code: JQP), ...
Dawning Technologies Inc focuses on interfacing solutions for clinical laboratories, IVD instruments, information system vendors and pharmaceutical/biotech companies. We produce javalin, jresultnet an more...
BD Biosciences Discovery Labware | Address: One Becton Circle, Durham, North Carolina 27712, USA
www.bdbiosciences.com | Phone: +1-(978)-901-7431
FDA Registration: 1054657
Products: Blood Diluting Pipettes, Diluting Pipette (FDA Code: GGY), Pipetting and Diluting Station (FDA Code: JQW), Hematology Quantitative Pipette (FDA Code: GJG), Microbiology Diagnostic Device (FDA Code: LIB), Assisted Reproduction Labware (FDA Code: MQK), ...
BD Biosciences Discovery Labware offers clinical diagnostic and research tools to life scientists, clinical researchers, laboratory professionals & clinicians. We are involved in basic research, drug more...
www.bdbiosciences.com | Phone: +1-(978)-901-7431
FDA Registration: 1054657
Products: Blood Diluting Pipettes, Diluting Pipette (FDA Code: GGY), Pipetting and Diluting Station (FDA Code: JQW), Hematology Quantitative Pipette (FDA Code: GJG), Microbiology Diagnostic Device (FDA Code: LIB), Assisted Reproduction Labware (FDA Code: MQK), ...
BD Biosciences Discovery Labware offers clinical diagnostic and research tools to life scientists, clinical researchers, laboratory professionals & clinicians. We are involved in basic research, drug more...
Oxoid Ltd. | Address: Wade Road, Basingstoke RG24 8PW, United Kingdom 
www.oxoid.com | Send Inquiry | Phone: +44-(1256)-841144
FDA Registration: 8010096 Employee Count: ~400 Quality: ISO 9000, ISO 13485 Certified
Products: Prostate-Specific Antigen for Management of Prostate Cancers (FDA Code: LTJ), Anaerobic Transport System (FDA Code: JTX), Antibiotic Assay Culture Media (FDA Code: JSA), Antimicrobial Susceptibility Test Disc (FDA Code: JTN), Antimicrobial Susceptibility Test Culture Media (FDA Code: JSO), Automated Antimicrobial Susceptibility Test System (FDA Code: LON), ...
Oxoid Ltd. manufactures and distributes microbiological culture media & other diagnostic products. Our products are used in clinical and industrial laboratories to isolate and identify the bacteria or more...
www.oxoid.com | Send Inquiry | Phone: +44-(1256)-841144
FDA Registration: 8010096 Employee Count: ~400 Quality: ISO 9000, ISO 13485 Certified
Products: Prostate-Specific Antigen for Management of Prostate Cancers (FDA Code: LTJ), Anaerobic Transport System (FDA Code: JTX), Antibiotic Assay Culture Media (FDA Code: JSA), Antimicrobial Susceptibility Test Disc (FDA Code: JTN), Antimicrobial Susceptibility Test Culture Media (FDA Code: JSO), Automated Antimicrobial Susceptibility Test System (FDA Code: LON), ...
Oxoid Ltd. manufactures and distributes microbiological culture media & other diagnostic products. Our products are used in clinical and industrial laboratories to isolate and identify the bacteria or more...
Medical Wire & Equipment Co. (bath), Ltd. | Address: Potley, Corsham, Wiltshire SN1 39RT, United Kingdom
www.mwe.co.uk | Send Inquiry | Phone: +44-(1225)-810-361
FDA Registration: 9610649 Annual Revenues: USD 5-10 Million Employee Count: ~80 Quality: ISO 9001, CE Certified
Products: Cotton Swabs, Quality Control Kits (FDA Code: JTR), Stainless Steel Surgical Wire, Sterile Cotton Swabs, Specimen Collection Device (FDA Code: LIO), Surgical Wire (FDA Code: LRN), ...
Medical Wire & Equipment Co. Ltd. offers products for veterinary, obstetrics and gynecology fields. We provide Transwabs® & Virocult®, Dryswabs®, specimen containers, Amnicators® and l more...
www.mwe.co.uk | Send Inquiry | Phone: +44-(1225)-810-361
FDA Registration: 9610649 Annual Revenues: USD 5-10 Million Employee Count: ~80 Quality: ISO 9001, CE Certified
Products: Cotton Swabs, Quality Control Kits (FDA Code: JTR), Stainless Steel Surgical Wire, Sterile Cotton Swabs, Specimen Collection Device (FDA Code: LIO), Surgical Wire (FDA Code: LRN), ...
Medical Wire & Equipment Co. Ltd. offers products for veterinary, obstetrics and gynecology fields. We provide Transwabs® & Virocult®, Dryswabs®, specimen containers, Amnicators® and l more...
Salubris Inc., | Address: Zumrutevler Mahallesi, Seher Sokak No: 41 Kat: 3 Aras Is Merkezi, Maltepe 34852, Turkey 
www.salubrisinc.com | Send Inquiry | Phone: +90-(216)-4421680
Products: Clinical Reference Laboratory, Respiratory Kit Disinfectants, Tuberculosis Card Test, Clinical Laboratory Tests, Respiratory Apparatus, Detergent (FDA Code: JCB), ...
Salubris Inc., is a provider of laboratory products and services in the fields of human and veterinary health. We specialize in tuberculosis diagnostic products. Our products include devices for the d more...
www.salubrisinc.com | Send Inquiry | Phone: +90-(216)-4421680
Products: Clinical Reference Laboratory, Respiratory Kit Disinfectants, Tuberculosis Card Test, Clinical Laboratory Tests, Respiratory Apparatus, Detergent (FDA Code: JCB), ...
Salubris Inc., is a provider of laboratory products and services in the fields of human and veterinary health. We specialize in tuberculosis diagnostic products. Our products include devices for the d more...
Integra Biosciences | Address: Industricstrasse 44, Wallisellen 8304, Switzerland
Phone: +41-(18)-30-2277
Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9000, CE Certified
Products: Laboratory Sterilizers, Volumetric Infusion Pumps, Infusion Pumps, Ambulatory Pumps, PCA Pumps, Infusion Pump, Dual-Channel Volumetric Infusion Pump, IV Medication Delivery Systems, volumetric infusion pumps, ...
Integra Biosciences is a provider of cell biology equipment and diagnostic test kits for infectious diseases. more...
Phone: +41-(18)-30-2277
Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9000, CE Certified
Products: Laboratory Sterilizers, Volumetric Infusion Pumps, Infusion Pumps, Ambulatory Pumps, PCA Pumps, Infusion Pump, Dual-Channel Volumetric Infusion Pump, IV Medication Delivery Systems, volumetric infusion pumps, ...
Integra Biosciences is a provider of cell biology equipment and diagnostic test kits for infectious diseases. more...
Electra-Box Diagnostica Ab | Address: Box 2035, Tyreso 13502, Sweden
www.electrabox.com | Send Inquiry | Phone: +46-(8)-44 87 370
Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Microbiology Diagnostic Device (FDA Code: LIB), Calibration Reagent, ...
Electra-Box Diagnostica Ab is a distributor of in-vitro laboratory products used in blood banking, research, immunology, clinical chemistry and microbiology. Our in vivo products are used in cardiolog more...
www.electrabox.com | Send Inquiry | Phone: +46-(8)-44 87 370
Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Microbiology Diagnostic Device (FDA Code: LIB), Calibration Reagent, ...
Electra-Box Diagnostica Ab is a distributor of in-vitro laboratory products used in blood banking, research, immunology, clinical chemistry and microbiology. Our in vivo products are used in cardiolog more...
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FDA Code / Regulation: LIB / 866.2660
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.
