Labeled Medical Laboratory Equipment Suppliers
Limit companies to: Worldwide USA
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...
Hazlet Medical Supplies | Address: 3253 New Jersey Highway 35, Hazlet, New Jersey 07730, USA
https://hazletmedicalsupplies.com | Send Inquiry | Phone: +1-(732)-847-3640
Products: General Medical Equipment, Biomedical Devices, Biomedical Devices, Medical Electronics Equipment, Hospital Durable Medical Equipment, Medical Diagnostic Equipment, ...
Hazlet Medical Supplies offers a vast amount of healthcare products, medical supplies and medical equipment. more...
https://hazletmedicalsupplies.com | Send Inquiry | Phone: +1-(732)-847-3640
Products: General Medical Equipment, Biomedical Devices, Biomedical Devices, Medical Electronics Equipment, Hospital Durable Medical Equipment, Medical Diagnostic Equipment, ...
Hazlet Medical Supplies offers a vast amount of healthcare products, medical supplies and medical equipment. more...
DRG International, Inc. | Address: 1167 US Highway 22 East, Mountainside, New Jersey 07092, USA
www.drg-international.com | Send Inquiry | Phone: +1-(908)-233-2075
FDA Registration: 2245285 Year Established: 1970 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9000, ISO 9001, CE Certified
Products: Laboratory Equipment, Incubators, Amylase, Incubator Shakers, Angiotensin II, Lyme Disease (Borrelia) Test Kits, ...
DRG International, Inc. is a multinational specialty medical equipment and diagnostics manufacturer & distributor. We offer products for enzyme immunoassays, rapid saliva & tumor tests, radio immunoas more...
www.drg-international.com | Send Inquiry | Phone: +1-(908)-233-2075
FDA Registration: 2245285 Year Established: 1970 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9000, ISO 9001, CE Certified
Products: Laboratory Equipment, Incubators, Amylase, Incubator Shakers, Angiotensin II, Lyme Disease (Borrelia) Test Kits, ...
DRG International, Inc. is a multinational specialty medical equipment and diagnostics manufacturer & distributor. We offer products for enzyme immunoassays, rapid saliva & tumor tests, radio immunoas more...
Globe Scientific Inc. | Address: 610 Winters Avenue, Paramus, New Jersey 07652, USA
www.globescientific.com | Send Inquiry | Phone: +1-(201)-599-1400, 800-394-4562
FDA Registration: 2244900 Year Established: 1982 Annual Revenues: USD 5-10 Million Employee Count: ~20
Products: Incubators, Hematology Analyzers, Urine Chemistry Analyzers, Automated Urine Chemistry Analyzers, Microscope Filter Sets, Laboratory Incubators (Non-C02), ...
Globe Scientific Inc. supplies laboratory plasticware, glassware and bench top equipments. Three types of 96-well microtest plates are offered for general (non-tissue-culture) applications including m more...
www.globescientific.com | Send Inquiry | Phone: +1-(201)-599-1400, 800-394-4562
FDA Registration: 2244900 Year Established: 1982 Annual Revenues: USD 5-10 Million Employee Count: ~20
Products: Incubators, Hematology Analyzers, Urine Chemistry Analyzers, Automated Urine Chemistry Analyzers, Microscope Filter Sets, Laboratory Incubators (Non-C02), ...
Globe Scientific Inc. supplies laboratory plasticware, glassware and bench top equipments. Three types of 96-well microtest plates are offered for general (non-tissue-culture) applications including m more...
Daxor Corporation | Address: Empire State Building, 350 Fifth Avenue, Suite 7120, New York, New York 10118, USA
www.daxor.com | Send Inquiry | Phone: +1-(212)-330-8500
FDA Registration: 3003529145
Products: Laboratory Equipment, Blood Volume Analyzer, Laboratory Equipment Devices, Blood Collection Tray (FDA Code: GJE), Enteral Irrigation Kit w/Piston Syringe, Piston Syringe (FDA Code: FMF), ...
Daxor Corporation is a medical instrumentation and biotechnology company. We have designed and developed the BVA-100 blood volume analyzer. It is the first instrument approved by the FDA to provide ra more...
www.daxor.com | Send Inquiry | Phone: +1-(212)-330-8500
FDA Registration: 3003529145
Products: Laboratory Equipment, Blood Volume Analyzer, Laboratory Equipment Devices, Blood Collection Tray (FDA Code: GJE), Enteral Irrigation Kit w/Piston Syringe, Piston Syringe (FDA Code: FMF), ...
Daxor Corporation is a medical instrumentation and biotechnology company. We have designed and developed the BVA-100 blood volume analyzer. It is the first instrument approved by the FDA to provide ra more...
Nalge Nunc International | Address: International Department, 75 Panorama Creek Drive, Rochester, New York 14625, USA
www.nalgenunc.com | Send Inquiry | Phone: +1-(800)-625-4327
FDA Registration: 1314344 Year Established: 1949 Annual Revenues: USD 100-500 Million Employee Count: ~900 Quality: ISO, CE Certified
Products: Microplate Washers, Vacuum Manifolds, Plate Sealing Films, Plate Sealing Foils, Centrifuge Aids, General Diagnostic Supplies, ...
Nalge Nunc International is an ISO 13485 certified company. Our hydrometer jar is a one-piece unit, which is transparent, has superior chemical resistance & an upper temperature limit of 135°C. It more...
www.nalgenunc.com | Send Inquiry | Phone: +1-(800)-625-4327
FDA Registration: 1314344 Year Established: 1949 Annual Revenues: USD 100-500 Million Employee Count: ~900 Quality: ISO, CE Certified
Products: Microplate Washers, Vacuum Manifolds, Plate Sealing Films, Plate Sealing Foils, Centrifuge Aids, General Diagnostic Supplies, ...
Nalge Nunc International is an ISO 13485 certified company. Our hydrometer jar is a one-piece unit, which is transparent, has superior chemical resistance & an upper temperature limit of 135°C. It more...
Brinkmann Instruments, Inc | Address: One Cantiague Road, P.O. Box 1019, Westbury, New York 11590-0207, USA
www.brinkmann.com | Send Inquiry | Phone: +1-(800)-645-3050
Year Established: 1967 Employee Count: ~30
Products: Laboratory Sterilizers, pH Monitoring System, Thermal Shakers, Microhematocrit Centrifuges, Vacuum Manifolds, Vacuum Pumps, ...
Brinkmann Instruments, Inc supplies laboratory products. We offer products like brinkman column chromatography, physical measurements, digesters, dispensing & dilution products, process analysers, ele more...
www.brinkmann.com | Send Inquiry | Phone: +1-(800)-645-3050
Year Established: 1967 Employee Count: ~30
Products: Laboratory Sterilizers, pH Monitoring System, Thermal Shakers, Microhematocrit Centrifuges, Vacuum Manifolds, Vacuum Pumps, ...
Brinkmann Instruments, Inc supplies laboratory products. We offer products like brinkman column chromatography, physical measurements, digesters, dispensing & dilution products, process analysers, ele more...
Tecan U.S., Inc. | Address: P.O. Box 13953,4022 Stirrup Creek Road, Suite 310, Durham, North Carolina 27703, USA
www.tecan.com | Send Inquiry | Phone: +1-(919)-361-5200, 800 338 3226
FDA Registration: 3003402518 Year Established: 1980 Annual Revenues: USD 100-500 Million Employee Count: ~1100 Quality: ISO 9001, CE Certified
Products: Laboratory Automation Systems, Hematology Workcells, Microplate Washers, In Situ Hybridization Systems, Microplate Incubators & Shakers, Multi-Label Microplate Readers, ...
Tecan U.S., Inc. specializes in the development, production, distribution and servicing of enabling solutions for the discovery of pharmaceutical substances, as well as for genomics, proteomics and di more...
www.tecan.com | Send Inquiry | Phone: +1-(919)-361-5200, 800 338 3226
FDA Registration: 3003402518 Year Established: 1980 Annual Revenues: USD 100-500 Million Employee Count: ~1100 Quality: ISO 9001, CE Certified
Products: Laboratory Automation Systems, Hematology Workcells, Microplate Washers, In Situ Hybridization Systems, Microplate Incubators & Shakers, Multi-Label Microplate Readers, ...
Tecan U.S., Inc. specializes in the development, production, distribution and servicing of enabling solutions for the discovery of pharmaceutical substances, as well as for genomics, proteomics and di more...
Teleflex Medical | Address: PO Box 12600, Research Triangle Park, North Carolina 27709, USA
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Medical Humidifiers, Oxygen Masks (FDA Code: BYG), Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Medical Humidifiers, Oxygen Masks (FDA Code: BYG), Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
Dynex Technologies | Address: 14340 Sullyfield Circle, Chantilly, Virginia 20151-1621, USA
www.dynextechnologies.com | Send Inquiry | Phone: +1-(703)-631-7800, 800-288-2354
FDA Registration: 1117676 Year Established: 1952 Annual Revenues: USD 50-100 Million Employee Count: ~50
Products: Microplate Washers, Automated Microplate Washer, Fully Automated Microplate Strip Washer, Microplate Washer Accessories, Microplate Automatic Washer, microplate reader, ...
Dynex Technologies is a developer of automated workstations, laboratory instruments, and associated consumables that enable scientists & clinicians to make breakthrough discoveries. Our product list c more...
www.dynextechnologies.com | Send Inquiry | Phone: +1-(703)-631-7800, 800-288-2354
FDA Registration: 1117676 Year Established: 1952 Annual Revenues: USD 50-100 Million Employee Count: ~50
Products: Microplate Washers, Automated Microplate Washer, Fully Automated Microplate Strip Washer, Microplate Washer Accessories, Microplate Automatic Washer, microplate reader, ...
Dynex Technologies is a developer of automated workstations, laboratory instruments, and associated consumables that enable scientists & clinicians to make breakthrough discoveries. Our product list c more...
Dako North America, Inc. | Address: 6392 Via Real, Carpinteria, California 93013, USA
www.dakousa.com | Send Inquiry | Phone: +1-(805)-566-6655, 800-235-5743
FDA Registration: 2022180 Annual Revenues: USD 25-50 Million Employee Count: ~180 Quality: ISO 9001 Certified
Products: Myoglobin (FDA Code: DDR), Ferritin (FDA Code: DBF), Anti-acetylcholine Receptor Alpha Monoclonal Antibody, Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Automated Slide Stainer (FDA Code: KPA), Microscope Slides (FDA Code: KEW), ...
Dako North America, Inc. focuses on tissue-based cancer diagnostics like immunohistochemistry, in situ hybridization, flow cytometry, bulk antibodies for turbidometry and ELISA kits. We provide reagen more...
www.dakousa.com | Send Inquiry | Phone: +1-(805)-566-6655, 800-235-5743
FDA Registration: 2022180 Annual Revenues: USD 25-50 Million Employee Count: ~180 Quality: ISO 9001 Certified
Products: Myoglobin (FDA Code: DDR), Ferritin (FDA Code: DBF), Anti-acetylcholine Receptor Alpha Monoclonal Antibody, Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Automated Slide Stainer (FDA Code: KPA), Microscope Slides (FDA Code: KEW), ...
Dako North America, Inc. focuses on tissue-based cancer diagnostics like immunohistochemistry, in situ hybridization, flow cytometry, bulk antibodies for turbidometry and ELISA kits. We provide reagen more...
Celerus Diagnostics | Address: 1005 Mark Ave, Carpinteria, California 93013, USA
www.celerusdiagnostics.com | Send Inquiry | Phone: +1-(805)-684-2009
Products: Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Automated Slide Stainer (FDA Code: KPA), Diagnostic Products, Medical Software Solutions, Labeled Medical Laboratory Equipment (FDA Code: LXG), General Purpose Reagent (FDA Code: LDT), ...
Celerus Diagnostics offers diagnostic products. Our Celerus Wave™ system uses revolutionary wave motion technology that accelerates processes, enables 15-minute IHC results, and improves turnaro more...
www.celerusdiagnostics.com | Send Inquiry | Phone: +1-(805)-684-2009
Products: Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Automated Slide Stainer (FDA Code: KPA), Diagnostic Products, Medical Software Solutions, Labeled Medical Laboratory Equipment (FDA Code: LXG), General Purpose Reagent (FDA Code: LDT), ...
Celerus Diagnostics offers diagnostic products. Our Celerus Wave™ system uses revolutionary wave motion technology that accelerates processes, enables 15-minute IHC results, and improves turnaro more...
Interscan Corp. | Address: P.O. Box 2496, Chatsworth, California 91313-2496, USA
www.gasdetection.com | Send Inquiry | Phone: +1-(818)-882-2331, 800-458-6153
FDA Registration: 2032709 Year Established: 1975 Annual Revenues: USD 25-50 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Real Time Temperature and Humidity Data Logger, Labeled Medical Laboratory Equipment (FDA Code: LXG), Environmental Atmospheric Gas Monitor, Breath monitoring Systems, ...
Interscan Corp. deals with toxic gas detection instruments. Our bad breath detector Halimeter® is the first unit specifically designed to measure volatile sulfur compounds (VSC) in a clinical sett more...
www.gasdetection.com | Send Inquiry | Phone: +1-(818)-882-2331, 800-458-6153
FDA Registration: 2032709 Year Established: 1975 Annual Revenues: USD 25-50 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Real Time Temperature and Humidity Data Logger, Labeled Medical Laboratory Equipment (FDA Code: LXG), Environmental Atmospheric Gas Monitor, Breath monitoring Systems, ...
Interscan Corp. deals with toxic gas detection instruments. Our bad breath detector Halimeter® is the first unit specifically designed to measure volatile sulfur compounds (VSC) in a clinical sett more...
Biocare Medical, LLC | Address: 4040 Pike Lane, Concord, California 94520, USA
www.biocare.net | Send Inquiry | Phone: +1-(800)-799-9499
FDA Registration: 3004140393
Products: Molecular Analyte Specific Reagents (ASR), Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Automated Slide Stainer (FDA Code: KPA), General Medical Equipment, Hematoxylin Stain (FDA Code: HYJ), Hematoxylin Stain Solution with Phosphotungstic Acid, ...
Biocare Medical manufactures & supplies immunostaning systems, histopathology, monoclonal and polyclonal antibodies. We offer androgen receptor, calcitonin, calponin and calretinin. more...
www.biocare.net | Send Inquiry | Phone: +1-(800)-799-9499
FDA Registration: 3004140393
Products: Molecular Analyte Specific Reagents (ASR), Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Automated Slide Stainer (FDA Code: KPA), General Medical Equipment, Hematoxylin Stain (FDA Code: HYJ), Hematoxylin Stain Solution with Phosphotungstic Acid, ...
Biocare Medical manufactures & supplies immunostaning systems, histopathology, monoclonal and polyclonal antibodies. We offer androgen receptor, calcitonin, calponin and calretinin. more...
CAL Glass For Research, Inc. | Address: 3012 Enterprise St., Costa Mesa, California 92626, USA
Send Inquiry | Phone: +1-(714)-546-7250
Year Established: 1960 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Micro Pipette (FDA Code: JRC), Labware, Buret, Burner, Labeled Medical Laboratory Equipment (FDA Code: LXG), Laboratory Manometer, Macro Pipette, ...
CAL Glass For Research, Inc. specializes in engineering & manufacturing of custom quartz and pyrex apparatus including turnkey distillation systems. We manufacture glass instruments, laboratory equipm more...
Send Inquiry | Phone: +1-(714)-546-7250
Year Established: 1960 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Micro Pipette (FDA Code: JRC), Labware, Buret, Burner, Labeled Medical Laboratory Equipment (FDA Code: LXG), Laboratory Manometer, Macro Pipette, ...
CAL Glass For Research, Inc. specializes in engineering & manufacturing of custom quartz and pyrex apparatus including turnkey distillation systems. We manufacture glass instruments, laboratory equipm more...
Progentech Limited | Address: 5885 Hollis St, Suite 155, Emeryville, California 94608, USA
www.progentech.com | Send Inquiry | Phone: +1-(510)-725-4767
Products: Genomic Hybridization Systems, DNA Testing, DNA Sequencing System, Molecular Diagnostic Services, Labeled Medical Laboratory Equipment (FDA Code: LXG), Automated Molecular Diagnostic Solutions, ...
Progentech Limited is a life science and molecular diagnostics company. We develop instrumentation for nucleic acid and protein purification and for molecular diagnostic testing. We provide products f more...
www.progentech.com | Send Inquiry | Phone: +1-(510)-725-4767
Products: Genomic Hybridization Systems, DNA Testing, DNA Sequencing System, Molecular Diagnostic Services, Labeled Medical Laboratory Equipment (FDA Code: LXG), Automated Molecular Diagnostic Solutions, ...
Progentech Limited is a life science and molecular diagnostics company. We develop instrumentation for nucleic acid and protein purification and for molecular diagnostic testing. We provide products f more...
Tiger Medical Products (us), Inc. | Address: 17328, Ventura Blvd., No. 245, Encino, California 91316, USA
Phone: +1-(310)-614-1997
Products: Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Patient Examination Gowns and Capes (FDA Code: FME), Automated Urinalysis System (FDA Code: KQO), Urinals (FDA Code: FNP), ...
Tiger Medical Products (us), Inc. provides tongue depressors, adhesive bandages, medical absorbent fibers, mechanical walkers and manual stethoscopes. more...
Phone: +1-(310)-614-1997
Products: Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Patient Examination Gowns and Capes (FDA Code: FME), Automated Urinalysis System (FDA Code: KQO), Urinals (FDA Code: FNP), ...
Tiger Medical Products (us), Inc. provides tongue depressors, adhesive bandages, medical absorbent fibers, mechanical walkers and manual stethoscopes. more...
Beckman Coulter, Inc. | Address: 4300 N. Harbor Boulevard P.O. Box 3100, Fullerton, California 92834-3100, USA
www.coulter.com | Phone: +001-(800)-742-2345
FDA Registration: 2050012 Year Established: 1934 Annual Revenues: > USD 1 Billion Employee Count: ~10100 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Blood Glucose Meters, Blood Pressure Measuring Equipment, Fetal Monitors, Otoscopes, Blood Bags For Dialysis, Blood & Intravenous (IV) Bottles, ...
Beckman Coulter, Inc. is a manufacturer of biomedical testing instrument systems, tests & supplies that simplify and automate laboratory processes. Spanning the biomedical testing continuum from medic more...
www.coulter.com | Phone: +001-(800)-742-2345
FDA Registration: 2050012 Year Established: 1934 Annual Revenues: > USD 1 Billion Employee Count: ~10100 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Blood Glucose Meters, Blood Pressure Measuring Equipment, Fetal Monitors, Otoscopes, Blood Bags For Dialysis, Blood & Intravenous (IV) Bottles, ...
Beckman Coulter, Inc. is a manufacturer of biomedical testing instrument systems, tests & supplies that simplify and automate laboratory processes. Spanning the biomedical testing continuum from medic more...
Cell Marque Corp. | Address: 6600 Sierra College Blvd., Rocklin, California 95677, USA
www.cellmarque.com | Send Inquiry | Phone: +1-(916)-746.8900
FDA Registration: 1649339
Products: Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Labeled Medical Laboratory Equipment (FDA Code: LXG), Cytokeratins (FDA Code: LYE), Quality Control Slide (FDA Code: LJG), Estrogen Receptor Antibody Immunohistochemistry Assay (FDA Code: MYA), General Purpose Reagent (FDA Code: LDT), ...
Cell Marque Corp. focuses on producing and marketing antibodies primarily for diagnostic immunohistochemistry. We serve pathology laboratories and research facilities. We hold two patents; the first o more...
www.cellmarque.com | Send Inquiry | Phone: +1-(916)-746.8900
FDA Registration: 1649339
Products: Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Labeled Medical Laboratory Equipment (FDA Code: LXG), Cytokeratins (FDA Code: LYE), Quality Control Slide (FDA Code: LJG), Estrogen Receptor Antibody Immunohistochemistry Assay (FDA Code: MYA), General Purpose Reagent (FDA Code: LDT), ...
Cell Marque Corp. focuses on producing and marketing antibodies primarily for diagnostic immunohistochemistry. We serve pathology laboratories and research facilities. We hold two patents; the first o more...
Nanogen Inc | Address: 10398 Pacific Center Ct, San Diego, California 92121, USA
www.nanogen.com | Phone: +1-(877)-626-6436
Year Established: 1993
Products: Myoglobin (FDA Code: DDR), Molecular Analyte Specific Reagents (ASR), Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Genetic Testing Equipment, Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), ...
Nanogen Inc focuses on diagnostics provide researchers, healthcare professionals and patients. We offer instrumentation, reagents and test kits. We develop biomedical and healthcare market products. more...
www.nanogen.com | Phone: +1-(877)-626-6436
Year Established: 1993
Products: Myoglobin (FDA Code: DDR), Molecular Analyte Specific Reagents (ASR), Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Genetic Testing Equipment, Multi Analyte Control (FDA Code: JJY), Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX), ...
Nanogen Inc focuses on diagnostics provide researchers, healthcare professionals and patients. We offer instrumentation, reagents and test kits. We develop biomedical and healthcare market products. more...
Sponsored Links
FDA Code / Regulation: LXG / 862.2050
General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.
Classification. Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 862.9. The device is 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.
