GTQClass I

Antistreptolysin - Titer/Streptolysin O Reagent

21 CFR 866.3720 / Microbiology

GTQ is the FDA product code for Antistreptolysin - Titer/Streptolysin O Reagent, a class I device type, regulated under 21 CFR 866.3720. As of 2026-09-10, FDA records hold 37 510(k) clearances under this code, the most recent dated 2005-12-14, and 4 recalls.

Classification record

Product code: GTQ
Device name: Antistreptolysin - Titer/Streptolysin O Reagent
Regulation: 21 CFR 866.3720
Device class: Class I
Review panel: Microbiology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 37
Ingested recalls: 4

Clearances, product code GTQ

By decision year

37 clearances under product code GTQ with a decision year between 1976 and 2005, 1991 the highest year at 8.

Show the numbers

510(k) clearances under FDA product code GTQ by decision year
Year	Clearances
1976	1
1979	1
1980	2
1981	1
1982	2
1983	2
1984	2
1985	4
1986	1
1987	1
1988	1
1989	3
1990	1
1991	8
1992	3
1993	2
1995	1
2005	1

Applicants with the most clearances

Product code GTQ

Applicants holding the most 510(k) clearances under product code GTQ
Applicant	Clearances
Biokit USA, Inc.	4
Analytical Products, Inc.	3
Beckman Instruments, Inc.	3
Behring Diagnostics, Inc.	3
Kallestad Diag, A Div. of Erbamont, Inc.	3
Texas Immunology, Inc.	2
Allied Fisher Scientific	1
Ampcor, Inc.	1
Biologics Intl., Inc.	1
Biotrax, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order