Biorex Labs L L C

FDA Filings

This page includes the latest FDA filings for Biorex Labs L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3009469260
• FEI Number: 3009469260
• Name: BIOREX LABS LLC
• Owner & Operator: Biorex Labs LLC
• Contact Address: 194 E. Wallings Road Suite 201; Broadview Heights OH 44147 US
• Official Correspondent:
  • Evelyn R Mirza
  • x-440-8243000-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 194 E. Wallings Road Suite 201; Broadview Heights, OH 44147 US
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00860009154025 Biorex Labs LLC	K-CHECK CONTROLS B1777	2022-12-12
GUDID 00860009154018 Biorex Labs LLC	DIAZO-CHEK B1009	2022-12-12
GUDID 00860009154001 Biorex Labs LLC	K-CHECK B1555	2022-12-12
JJX BIOREX LABS LLC	K-CHECK CONTROLS	2018-08-27
JIN BIOREX LABS LLC	K-CHECK	2015-02-03
JJB BIOREX LABS LLC	DIAZO-CHEK	2013-07-16
JTO BIOREX LABS LLC	PYR reagent MicroDropper	2012-03-30
JTO BIOREX LABS LLC	PYR XeroStrips	2012-03-30
JTO BIOREX LABS LLC	PYR Disks	2012-03-30
JTO BIOREX LABS LLC	PYR Color developer	2012-03-30
JTO BIOREX LABS LLC	Oxidase reagent MicroDropper	2012-03-30
JTO BIOREX LABS LLC	Oxidase XeroStrips	2012-03-30
JTO BIOREX LABS LLC	Nitrocefin XeroStrips	2012-03-30
JTO BIOREX LABS LLC	Nitrocefin Disks	2012-03-30
JTO BIOREX LABS LLC	MycoLast Red	2012-03-30
JTO BIOREX LABS LLC	MycoLast Blue	2012-03-30
JTO BIOREX LABS LLC	McFarland Turbity Standards (Latex)	2012-03-30
JTO BIOREX LABS LLC	McFarland Standards, Barium Sulfate	2012-03-30
JTO BIOREX LABS LLC	Indole reagent Microdropper	2012-03-30
JTO BIOREX LABS LLC	Indole XeroStrips	2012-03-30
JTO BIOREX LABS LLC	Indole DMACA reagent	2012-03-30
JTO BIOREX LABS LLC	Indole DMABA reagent	2012-03-30
JTO BIOREX LABS LLC	Catalase reagents	2012-03-30
JSK BIOREX LABS LLC	Sterile Physiological Saline	2012-03-30
JSK BIOREX LABS LLC	Phosphate Buffer 6.8	2012-03-30
JSK BIOREX LABS LLC	Oxalic acid 5%	2012-03-30
JSK BIOREX LABS LLC	NALC, N acetyl L Cysteine	2012-03-30
JSK BIOREX LABS LLC	LYE-NAC Digestant	2012-03-30
JSK BIOREX LABS LLC	Bovine Serum Albumin BSA 0.5%	2012-03-30
JSJ BIOREX LABS LLC	GN Broth	2012-03-30
JSG BIOREX LABS LLC	Thioglycollate medium, W/ Hemin, K1, without indicator	2012-03-30
JSF BIOREX LABS LLC	Rapid Ornithine decarboxylase	2012-03-30
JSD BIOREX LABS LLC	Lim Broth	2012-03-30
JSC BIOREX LABS LLC	Cryobac Vials without beads	2012-03-30
JSC BIOREX LABS LLC	CryoBac Vials with beads	2012-03-30