Product code GTQ— Microbiology

FDA has cleared 37 devices under product code GTQ between 1976 and 2005, filed by 25 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20051 clearance
• 19951 clearance
• 19932 clearances
• 19923 clearances
• 19918 clearances
• 19901 clearance
• 19893 clearances
• 19881 clearance
• 19871 clearance
• 19861 clearance
• 19854 clearances
• 19842 clearances
• 19832 clearances
• 19822 clearances
• 19811 clearance

• Biokit USA, Inc.4 clearances
• Kallestad Diag, A Div. of Erbamont, Inc.3 clearances
• Behring Diagnostics, Inc.3 clearances
• Beckman Instruments, Inc.3 clearances
• Analytical Products, Inc.3 clearances
• Texas Immunology, Inc.2 clearances
• Syn-Kit, Inc.1 clearance
• Simplicity Diagnostics, Inc.1 clearance
• Sclavo, Inc.1 clearance
• Ortho-Clinical Diagnostics1 clearance

• K052645 — VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873Ortho-Clinical Diagnostics·2005-12-14
• K953437 — OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.·1995-10-20
• K915742 — TURBIQUANT ASLBehring Diagnostics, Inc.·1993-06-28
• K926236 — BECKMAN ANTI-STREPTOLYSIN O KITBeckman Instruments, Inc.·1993-06-15
• K924247 — ACCUTEX ASO LATEX TESTJ.S. Medical Assoc.·1992-12-07
• K922723 — TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROLSimplicity Diagnostics, Inc.·1992-09-18
• K915053 — BECKMAN ANTISTREPTOLYSIN O, MODIFICATIONBeckman Instruments, Inc.·1992-03-19
• K912150 — BECKMAN ANTI-STREPTOLYSIN O (ASO) KITBeckman Instruments, Inc.·1991-07-17
• K904416 — CROATEST (R) RHEUMATOID DIAGNOSTICBiotrax, Inc.·1991-06-24
• K910885 — QM300 CALIBRATOR G PACKKallestad Diag, A Div. of Erbamont, Inc.·1991-06-17
• K910886 — QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACKKallestad Diag, A Div. of Erbamont, Inc.·1991-06-17
• K910887 — QM300 CONTROL G PACKKallestad Diag, A Div. of Erbamont, Inc.·1991-06-17
• K910073 — TARGET ASO TESTTexas Immunology, Inc.·1991-05-21
• K903854 — RAPITEX(R) ASL NEWBehring Diagnostics, Inc.·1991-01-28
• K904311 — RHEUMAGEN ASO T-CONTROLBiokit USA, Inc.·1991-01-25
• K901371 — ASO-CUBE(TM)Difco Laboratories, Inc.·1990-05-15
• K894486 — QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL)Biokit USA, Inc.·1989-10-24
• K894780 — IMMUNO/ASOImmunostics Co., Inc.·1989-10-16
• K890025 — QUIK-DOT ANTISTREPTOLYSIN-OAmpcor, Inc.·1989-01-31
• K881209 — ASO SLIDE TESTNcs Diagnostics, Inc.·1988-04-12
• K862530 — RAPID AS LATEXDilab, Inc.·1987-04-21
• K854991 — REUMAGEN ASLBiokit USA, Inc.·1986-04-18
• K854039 — LASER ASO KITBehring Diagnostics, Inc.·1985-10-28
• K853857 — V-TREND ASO PLUS LATEX TESTTexas Immunology, Inc.·1985-10-16
• K853276 — ASO SLIDE EIKENSyn-Kit, Inc.·1985-08-20
• K852701 — FISHER DIAGNOSTIC LATEST ASO TEST KITAllied Fisher Scientific·1985-07-19
• K842839 — SERIMM SURE ASO-CHEK CONTROL SERUMAnalytical Products, Inc.·1984-08-23
• K842256 — AS LATEX PLUSBiokit USA, Inc.·1984-06-19
• K831464 — ASO-CHECKDiagnostic Technology, Inc.·1983-06-16
• K831363 — TESTCORP ASOCatheter Technology Corp.·1983-05-16
• K820785 — ASO SUREAnalytical Products, Inc.·1982-04-08
• K820786 — ASO SURE PLUSAnalytical Products, Inc.·1982-04-08
• K812060 — BI-ASO SLIDE TESTBiologics Intl., Inc.·1981-08-13
• K801177 — ASO QUANTUM, ANTISTREPTOLYSIN O TESTSclavo, Inc.·1980-07-08
• K800642 — RAPI/TEX ASO STANDARD SERUMCalbiochem-Behring Corp.·1980-04-24
• K790831 — ANTISTREPTOLYSIN (ASO) LATEX SLIDE TESTIcl Scientific·1979-06-15
• K760096 — REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN OGamma Biologicals, Inc.·1976-08-03