FDA.report

BIOGENEX LABORATORIES INC.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30087761652936532BIOGENEX LABORATORIES INC.1N2026-01-0148810 Kato Road,Suite 100E&200E Fremont CA US 94538

GUDID Contact Samples

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

Source GUDIDProductPhoneEmail
00810119675187ANTI-PAX5 - MU967-UC+1 (800) 421-4149support@biogenex.com
00810119675972ANTI-HLA-DR - MU154-UC+1 (800) 421-4149support@biogenex.com
00810119676061Anti- c-Myc - NUC25-UC+1 (800) 421-4149support@biogenex.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1241961971473325K013148BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)MYA2002-02-28
1241961484253609K012960BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTORMXZ2002-03-08
1241961002329263
1241961022027537
1241961032721213
1241961069029538
1241961125367771
1241961131470959
1241961145383235
1241961147991307
1241961187460818
1241961191575232
1241961205623826
1241961214851555
1241961294834565
1241961374674631
1241961433065589
1241961488254672
1241961502012370
1241961538738488
1241961575265190
1241961580889450
1241961589898353
1241961599053849
1241961617730217
1241961652223435
1241961653366556
1241961687950889
1241961776494261
1241961792797187
1241961859814223
1241961870445401
1241961884213555
1241961913263927
1241961957703392
1241962016239152

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
MXZ12002-03-08
MYA12002-02-28

PMN

GUDID

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