FDA.reportPublic FDA data

TRINITY BIOTECH, PLC

Matched from indexed company URL: Trinity Biotech, Plc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96815763002546385TRINITY BIOTECH, PLC1N2026-01-01IDA BUSINESS PARK BRAY Wicklow IE --

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
520751589839524K933934GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-AJBF1995-06-29
520751663790335K883525OXALATE REAGENTLPW1988-10-25
520751852466546K873342BILE ACIDS CONTROLSJJX1987-10-20
520751763197355K872451BILE ACIDS CALIBRATORJIT1987-08-21
520751453096161K872296BILE ACIDS REAGENTKWW1987-08-26
520751895816954K854245SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UVKQN1986-01-22
520751499334450K842366OXALATE URINE CONTROLS NORMAL & ELEVATJJW1984-09-12
520751201924772K790211DEHYDROGENOSE, GLUCOSE PHOSPHATEJBL1979-03-15
520751942281819BP030025
520751735875188BK120021
520751238670299
520751347267266
520751466073559
520751573696518
520751608213652
520751838286270

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JBF11995-06-29
LPW11988-10-25
JJX11987-10-20
KWW11987-08-26
JIT11987-08-21
KQN11986-01-22
JJW11984-09-12
JBL11979-03-15

PMN#