Is this your brand? Sign in to claim ownership.
Sign in to claim this brandPrimus Corp.
US
Last updated May 23, 2026
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (72)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Trinity Biotech | PDQ Diluent Reagent - 940mL | FDA UDI | Class II | Active |
| Trinity Biotech | Ultra2 Resolution Variants Analyzer | FDA UDI | Class II | Active |
| Trinity Biotech | Premier Hb9210 HbA1c Analytical Column (4000) | FDA UDI | Class II | Active |
| Trinity Biotech | PDQ Wash Reagent | FDA UDI | Class II | Active |
| Trinity Biotech | HbA1c (GHb) Calibrator Kit, 500uL (Levels 1 & 2) - 1 kit | FDA UDI | Class II | Active |
| Trinity Biotech | Premier Wash Reagent - 940mL | FDA UDI | Class II | Active |
| Trinity Biotech | Genesys 1 Reagent - 3.8L | FDA UDI | Class II | Active |
| Trinity Biotech | Tri-stat 2 Analyzer | FDA UDI | Class II | Active |
| Primus Model Clc 330 | K891235 | FDA 510(k) | Class II | Active |
| Glycated Protein Controls | K940142 | FDA 510(k) | Class I | Active |
| Primus Variant System Pvs99 | K955283 | FDA 510(k) | Class II | Active |
| Primus Rapid Gel 100 Glycated Hemoglobin Assay | K942009 | FDA 510(k) | Class II | Active |
| Diabetes Care(tm) Test Package For The Clc 330(tm) | K896582 | FDA 510(k) | Class II | Active |
| Nycocard Crp Control | K014084 | FDA 510(k) | Class II | Active |
| Primus Liquid Calibrator For Ghb/A1c Level 1 And Level 2 | K994045 | FDA 510(k) | Class II | Active |
| Nycocard Hba1c Glycosylated Hemoglobin Assay | K993131 | FDA 510(k) | Class II | Active |
| Primus Liquid Control For Ghb/Alc Level I And Level Ii | K992921 | FDA 510(k) | Class II | Active |
| Nycocard Crp | K013787 | FDA 510(k) | Class II | Active |
| Glycated Hemoglobin Calibrators | K936204 | FDA 510(k) | Class II | Active |
| Glycated Hemoglobin Controls | K940143 | FDA 510(k) | Class II | Active |
| Primus A1care Assay | K062658 | FDA 510(k) | Class II | Active |
| Glycated Protein Calibrators | K940008 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 9, 2020 | Z-0321-2021 | — | terminated | The product did not receive pre-market approval or clearance. |