FDA.reportPublic FDA data

BioReference Health, LLC

Matched from indexed company URL: Bioreference Health, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30036526723003652672BioReference Health, LLC1N2026-01-01481 Edward H. Ross Drive Elmwood Park NJ US 07407

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
008500388600044Kscore Test - 4Kscore Specimen Collection Kit800.229.5227bamaral@bioreference.com
008500388600044Kscore Test - 4Kscore Specimen Collection Kit800-229-5227ksiedel@bioreference.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3015271361400951P1900224Kscore TestQRF2021-12-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QRF 12021-12-07

GUDID#