FDA.reportPublic FDA data

Trinity Biotech (Primus Corporation dba Trinity Biotech)

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
19312511931251Trinity Biotech (Primus Corporation dba Trinity Biotech)1N2026-01-014231 E 75th Ter KANSAS CITY MO US 64132

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
163621319373783K994045PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2LCP1999-12-21
163621046009633K955283PRIMUS VARIANT SYSTEM PVS99GKA1996-03-01
163621990134754K891235PRIMUS MODEL CLC 330LCP1989-06-16
163621609071391K222635Premier Resolution SystemGKA2023-08-04
163621114133121K112015PREMIER HB9210 HBA1C ANALYZERLCP2011-11-22
163621700129461K062658PRIMUS A1CARE ASSAYLCP2007-11-26
163621087202682
163621300202185

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LCP42011-11-22
GKA22023-08-04