Data / Medical devices / Antisera, All Groups, Streptococcus Spp.

Antisera, All Groups, Streptococcus Spp. (GTZ): 16 FDA-registered makers in 6 countries

Name: FDA-registered makers of Antisera, All Groups, Streptococcus Spp.
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

16 establishments in 6 countries are registered with the FDA to make Antisera, All Groups, Streptococcus Spp. (product code GTZ, Class 1, 21 CFR 866.3740). 8 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 105 510(k) clearances under this code, the latest on November 30, 2001, and lists 3 recall events (0 Class I). FDA data exported November 3, 2026.

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Product code: GTZ
Device class: 1
Regulation: 866.3740
Medical specialty: Microbiology

Makers by country

Country	Makers
United States	9
United Kingdom	2
Mexico	2
Greece	1
Denmark	1
Canada	1

Makers of Antisera, All Groups, Streptococcus Spp.

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Remel Europe Ltd	Dartford, Kent, United Kingdom	Contract manufacturer, Manufacturer	4	March 29, 1991	0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	San Diego, CA, United States	Specification developer	3	April 15, 1996	0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Carlsbad, CA, United States	Manufacturer	3	April 15, 1996	0	api.fda.gov
Quidel Corp.	San Diego, CA, United States	Complaint file establishment, Manufacturer	3	April 15, 1996	0	api.fda.gov
Abbott Diagnostics Scarborough, Inc.	Scarborough, ME, United States	Manufacturer	2	November 30, 2001	1	api.fda.gov
Abbott Diagnostics Scarborough, Inc.	Westbrook, ME, United States	Manufacturer	2	November 30, 2001	0	api.fda.gov
Oxoid, Ltd.	Basingstoke, Hampshire, United Kingdom	Exporter to the US, Specification developer	1	March 11, 1986	0	api.fda.gov
Sekisui Diagnostics, LLC	San Diego, CA, United States	Contract manufacturer, Manufacturer	1	October 11, 1996	0	api.fda.gov
Becton, Dickinson & Co.	Sparks, MD, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
CTK Biotech, Inc.	Poway, CA, United States	Manufacturer	0		0	api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.	Woodland Hills, CA, United States	Manufacturer	0		0	api.fda.gov
Laboratorios Scantibodies S.A. De C.V.	TECATE Baja California, Mexico	Contract manufacturer	0		0	api.fda.gov
Laboratorios Scantibodies, S.A. de C.V.	Tijuana Baja California, Mexico	Contract manufacturer	0		0	api.fda.gov
Medicon Hellas SA	GERAKAS Attiki, Greece	Manufacturer	0		0	api.fda.gov
SSI Diagnostica A/S	Hilleroed Hovedstaden, Denmark	Manufacturer	0		0	api.fda.gov
pro-lab incorporated	Richmond Hill Ontario, Canada	Contract manufacturer, Manufacturer	0		0	api.fda.gov

Updated November 30, 2001. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.