Product code GOL— Microbiology

FDA has cleared 21 devices under product code GOL between 1976 and 1984, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19842 clearances
• 19811 clearance
• 19809 clearances
• 19794 clearances
• 19774 clearances
• 19761 clearance

• Flow Laboratories, Inc.3 clearances
• Abbott Laboratories3 clearances
• Litton Bionetics2 clearances
• Intl. Diagnostic Technology2 clearances
• Cordis Corp.2 clearances
• Calbiochem-Behring Corp.2 clearances
• Ortho Diagnostics, Inc.1 clearance
• Microbiological Research Corp.1 clearance
• M.A. Bioproducts1 clearance
• Clinical Assays, Inc.1 clearance

• K841174 — RUBELLA ANTIBODY FLUOROIMMUNOASSAYIntl. Diagnostic Technology·1984-06-07
• K834032 — RUBAQUICK DIAGNOSTIC KITAbbott Laboratories·1984-04-17
• K810309 — RUBELLA ANTIBODIES TEST REAGENTSCalbiochem-Behring Corp.·1981-03-11
• K802102 — RUBELLA ELISA REAGENTS RUBELLA IGG ANTICalbiochem-Behring Corp.·1980-12-18
• K802339 — EIA RUBELLA-GBeckman Instruments, Inc.·1980-12-18
• K802508 — RUBELISA IGM TEST KITM.A. Bioproducts·1980-12-18
• K801667 — GAMMA COAT(125 I) RUBELLA ANTIBODYClinical Assays, Inc.·1980-10-23
• K801098 — ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES)Flow Laboratories, Inc.·1980-09-16
• K801507 — ANTIGEN CONTROL CELLSOrtho Diagnostics, Inc.·1980-08-20
• K800789 — RUBELLA BIO-BEAD TITRATION KITLitton Bionetics·1980-06-30
• K800797 — MACRO-VUE RUBELLA CARD TESTBd Becton Dickinson Vacutainer Systems Preanalytic·1980-06-20
• K792249 — FIAX TEST KIT FOR ANTI-RUBELLA ANTIBODIntl. Diagnostic Technology·1980-01-23
• K791610 — RUBELLA BIO-BEAD SCREEN KITLitton Bionetics·1979-11-13
• K790976 — RUBAZYMEAbbott Laboratories·1979-08-16
• K790212 — CORDIA TCordis Corp.·1979-04-12
• K780885 — CORDIA RCordis Corp.·1979-01-17
• K771796 — RUBA-NOST TEST KITSBehring Diagnostics, Inc.·1977-10-18
• K770805 — MEASLES-FA LABELLED (8-441 RF)Flow Laboratories, Inc.·1977-05-20
• K770809 — MEASLES-FA LABELED PRESERUM (8-441 RNF)Flow Laboratories, Inc.·1977-05-20
• K770092 — HERPESIVIRUS TEST (TYPE L & 2)Microbiological Research Corp.·1977-03-01
• K760889 — TEST FOR DETECTION OF ANTIRUBELLA ANTIBAbbott Laboratories·1976-11-16