GTZClass I

Antisera, All Groups, Streptococcus Spp.

21 CFR 866.3740 / Microbiology

GTZ is the FDA product code for Antisera, All Groups, Streptococcus Spp., a class I device type, regulated under 21 CFR 866.3740. As of 2026-09-10, FDA records hold 105 510(k) clearances under this code, the most recent dated 2001-11-30, and 3 recalls.

Classification record

Product code: GTZ
Device name: Antisera, All Groups, Streptococcus Spp.
Regulation: 21 CFR 866.3740
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: 105
Ingested recalls: 3

Clearances, product code GTZ

By decision year

105 clearances under product code GTZ with a decision year between 1976 and 2001, 1985 the highest year at 13.

Show the numbers

510(k) clearances under FDA product code GTZ by decision year
Year	Clearances
1976	1
1978	1
1979	1
1980	3
1982	2
1983	3
1984	5
1985	13
1986	12
1987	12
1988	7
1989	8
1990	5
1991	4
1992	4
1993	2
1994	3
1995	7
1996	6
1997	1
1998	1
1999	1
2001	3

Applicants with the most clearances

Product code GTZ

Applicants holding the most 510(k) clearances under product code GTZ
Applicant	Clearances
Abbott Medical	9
Ortho-Clinical Diagnostics, Inc.	8
BD Becton Dickinson Vacutainer Systems Preanalytic	7
Binax, Inc.	4
Siemens Healthcare Diagnostics Inc.	4
Pharmacia, Inc.	4
Armkel, LLC	3
Difco Laboratories, Inc.	3
Leeco Diagnostics, Inc.	3
Medix Biotech, Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order