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BIOREX LABS LLC

Matched from indexed company URL: Biorex Labs LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30094692603009469260BIOREX LABS LLC1N2026-01-018041 Broadview Rd Broadview Heights OH US 44147

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860009154001K-CHECK - The K-Check tablet is a chromogenic reagent to be used by trained laboratory professionals to determine the qualitative /semi-quantitative presence of two Ketone bodies i.e. acetone and acetoacetic acid in Urine, Serum, Plasma or Whole blood. The test results are read visually.440-824-3000info@biorexlabs.com
00860009154018DIAZO-CHEK - The DIAZO-CHEK test is used to qualitatively detect bilirubin in urine or confirm the positive results obtained by a reagent strip. The Test is intended for use by the appropriately trained laboratory professionals. The test consists of Reagent discs and the test pads which bind the bilirubin from a Urine specimen. The test is based on the diazo coupling reaction between the adsorbed bilirubin and a stabilized diazonium salt of Nitrobenzene. The reaction results in the development of varying grades of purple to bluish-purple color which is easily visible by the naked eye.440-824-3000info@biorexlabs.com
00860009154025K-CHECK CONTROLS - The K-CHECK Controls are intended to be used by trained laboratory professionals to evaluate and verify the expected accuracy and performance of K-CHECK Reagent tablets. The set of three controls consist of Levels 0, 1 and 2. The matrix used to manufacture the controls is a synthetic serum-like matrix and therefore free of potential infectious agents. The results are read visually by comparing to the color chart provided in the product insert. An opened vial is good for 30 days. An unopened vial has an expiration of one year.440-824-3000info@biorexlabs.com

Registered Device Listings#

Registration key, Listing key table
Registration keyListing key
1400151040912838
1400151053843414
1400151140221712
1400151376061081
1400151513098217
1400151515677528
1400151954946374
1400151330151168
1400151885657403
1400152040584492

GUDID#

DIAZO-CHEK - The DIAZO-CHEK test is used to qualitatively detect bilirubin in urine or confirm the positive results obtained by a reagent strip. The Test is intended for use by the appropriately trained laboratory professionals. The test consists of Reagent discs and the test pads which bind the bilirubin from a Urine specimen. The test is based on the diazo coupling reaction between the adsorbed bilirubin and a stabilized diazonium salt of Nitrobenzene. The reaction results in the development of varying grades of purple to bluish-purple color which is easily visible by the naked eye.

Biorex Labs LLC

2022-12-02

K-CHECK CONTROLS - The K-CHECK Controls are intended to be used by trained laboratory professionals to evaluate and verify the expected accuracy and performance of K-CHECK Reagent tablets. The set of three controls consist of Levels 0, 1 and 2. The matrix used to manufacture the controls is a synthetic serum-like matrix and therefore free of potential infectious agents. The results are read visually by comparing to the color chart provided in the product insert. An opened vial is good for 30 days. An unopened vial has an expiration of one year.

Biorex Labs LLC

2022-12-02