Data / Medical devices / Culture Media, Enriched

Culture Media, Enriched (KZI): 17 FDA-registered makers in 5 countries

Name: FDA-registered makers of Culture Media, Enriched
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

17 establishments in 5 countries are registered with the FDA to make Culture Media, Enriched (product code KZI, Class 1, 21 CFR 866.2330). 1 of them has a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 51 510(k) clearances under this code, the latest on October 25, 1988, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: KZI
Device class: 1
Regulation: 866.2330
Medical specialty: Microbiology

Makers by country

Country	Makers
United States	12
India	2
Taiwan	1
China	1
United Kingdom	1

Makers of Culture Media, Enriched

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, Inc.	Lenexa, KS, United States	Manufacturer	1	June 2, 1988	1	api.fda.gov
Alpha Biosciences, Inc.	Baltimore, MD, United States	Manufacturer, Remanufacturer, Repackager or relabeler	0		0	api.fda.gov
Anaerobe Systems	Morgan Hill, CA, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Analytichem Usa, Inc.	Winslow, ME, United States	Manufacturer	0		0	api.fda.gov
Becton, Dickinson & Co.	Sparks, MD, United States	Complaint file establishment, Specification developer	0		1	api.fda.gov
Becton, Dickinson & Co.	Cockeysville, MD, United States	Manufacturer	0		0	api.fda.gov
Creative Life Science Co., Ltd.	Xinzhuang District New Taipei, Taiwan	Manufacturer	0		0	api.fda.gov
Hardy Diagnostics	Orcutt, CA, United States	Manufacturer	0		0	api.fda.gov
Himedia Laboratories Private Limited	DOMBIVLI, THANE Maharashtra, India	Manufacturer	0		0	api.fda.gov
Himedia Laboratories Private Limited	NASHIK Maharashtra, India	Manufacturer	0		0	api.fda.gov
Hardy Diagnostics	Springboro, OH, United States	Manufacturer	0		0	api.fda.gov
Jinan Babio Biotechnology Co.,ltd.	Jinan City Shandong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Legacy Biologicals	Baltimore, MD, United States	Manufacturer	0		0	api.fda.gov
Oxford Immunotec Ltd	Abingdon Oxfordshire, United Kingdom	Manufacturer	0		0	api.fda.gov
Oxyrase, Inc.	Mansfield, OH, United States	Manufacturer	0		0	api.fda.gov
Puritan Medical Products Company LLC	Guilford, ME, United States	Manufacturer	0		0	api.fda.gov
S2media	Spokane Valley, WA, United States	Manufacturer	0		0	api.fda.gov

Updated October 25, 1988. 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.