| Primary Device ID | 05391516744768 |
| NIH Device Record Key | 6e8b27e3-2eec-4259-abfb-659f525d0c0b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Trinity Biotech |
| Version Model Number | Premier Buffer A Reagent - 940mL |
| Catalog Number | 01-03-0095 |
| Company DUNS | 790074793 |
| Company Name | PRIMUS CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Total Volume | 940 Milliliter |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05391516744768 [Primary] |
| LCP | Assay, Glycosylated Hemoglobin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-06 |
| 05391516748322 | Hemoglobin variants assay, Premier Resolution A2+F Control Material Kit |
| 05391516748315 | Hemoglobin variants assay, Premier Resolution A2+F Calibrator Kit |
| 05391516748216 | Hemoglobin A1c assay, Tri-stat Liquid Controls Kit |
| 05391516744409 | Hemoglobin variants assay, A2+F Control Material Kit |
| 05391516744393 | Hemoglobin variants assay, FASC Position Marker Kit |
| 05391516748636 | Hemoglobin A1c assay, PDQ Wash Reagent |
| 05391516748629 | Hemoglobin A1c assay, PDQ Diluent Reagent - 940mL |
| 05391516748612 | Hemoglobin A1c assay, PDQ 2 Reagent - 940mL |
| 05391516748605 | Hemoglobin A1c assay, PDQ1 Reagent - 940mL |
| 05391516748223 | Hemoglobin A1c assay, Tri-stat Reagent Kit |
| 05391516748193 | Hemoglobin variants assay, Genesys Diluent Reagent - 3.8L |
| 05391516748186 | Hemoglobin variants assay, Ultra2 Resolution 500 kit |
| 05391516748179 | Hemoglobin variants assay, Ultra2 Resolution Variants Analyzer |
| 05391516748162 | Hemoglobin A1c assay, Ultra2 Affinity A1c 3000 |
| 05391516748155 | Hemoglobin A1c assay, Ultra2 Affinity HbA1c Analyzer (110V) |
| 05391516748148 | Hemoglobin A1c assay, Premier Affinity A1c 3000 - 1 kit |
| 05391516748131 | Hemoglobin A1c assay, Premier Affinity A1c 1000 - 1 kit |
| 05391516748124 | Hemoglobin A1c assay, Premier Affinity A1c 500 - 1 kit |
| 05391516748117 | Hemoglobin A1c assay, Premier Sample Diluent Reagent - 940mL |
| 05391516748100 | Hemoglobin A1c assay, Premier Buffer B Reagent - 3.8L |
| 05391516748094 | Hemoglobin A1c assay, Premier Buffer A Reagent - 3.8L |
| 05391516748087 | Hemoglobin A1c assay, HbA1c (GHb) Controls Kit, 500uL (Levels I & II) - 1 kit |
| 05391516748070 | Hemoglobin A1c assay, HbA1c (GHb) Calibrator Kit, 500uL (Levels 1 & 2) - 1 kit |
| 05391516748063 | Hemoglobin A1c assay, Premier Hb9210 HbA1c Analytical Column (500) |
| 05391516748056 | Hemoglobin A1c assay, Premier Hb9210 HbA1c Analytical Column (1000) |
| 05391516744812 | Hemoglobin A1c assay, HbA1c (GHb) Calibrator Kit, 400uL (Levels 1 & 2) - 1 kit |
| 05391516744799 | Hemoglobin A1c assay, Premier Wash Reagent - 940mL |
| 05391516744782 | Hemoglobin A1c assay, Premier Diluent Reagent - 3.8L |
| 05391516744775 | Hemoglobin A1c assay, Premier Buffer B Reagent - 940mL |
| 05391516744768 | Hemoglobin A1c assay, Premier Buffer A Reagent - 940mL |
| 05391516744751 | Hemoglobin A1c assay, Premier Hb9210 HbA1c Analyzer |
| 05391516744553 | Hemoglobin A1c assay, Affinity Analytical Column |
| 05391516744546 | Hemoglobin A1c assay, Enzyme Cleaner Tube |
| 05391516744539 | Hemoglobin variants assay, Genesys Analytical Column |
| 05391516744522 | Hemoglobin variants assay, Resolution Analytical Column |
| 05391516744379 | Hemoglobin A1c assay, HbA1c (GHb) Controls Kit, 400uL (Levels I & II) - 1 kit |
| 05391516744317 | Hemoglobin A1c assay, 2 Diluent Reagent - 940mL |
| 05391516744294 | Hemoglobin A1c assay, 2 Diluent Reagent - 3.8L |
| 05391516744287 | Hemoglobin A1c assay, Ultra2 Buffer 2A Reagent - 3.8L |
| 05391516744270 | Hemoglobin A1c assay, Ultra2 Buffer 2A Reagent - 940mL |
| 05391516744263 | Hemoglobin variants assay, Mobile Phase 2 Reagent - 940mL |
| 05391516744256 | Hemoglobin variants assay, Mobile Phase 1 Reagent - 940mL |
| 05391516744249 | Hemoglobin variants assay, Mobile Phase 2 Reagent - 3.8L |
| 05391516744232 | Hemoglobin variants assay, Mobile Phase 1 Reagent - 3.8L |
| 05391516744218 | Hemoglobin A1c assay, System Wash Reagent - 940mL |
| 05391516744201 | Hemoglobin variants assay, Genesys 2 Reagent - 3.8L |
| 05391516744195 | Hemoglobin variants assay, Genesys 1 Reagent - 3.8L |
| 05391516744171 | Hemoglobin A1c assay, Ultra2 Buffer B Reagent - 3.8L |
| 05391516744164 | Hemoglobin A1c assay, Ultra2 Buffer B Reagent - 940mL |
| 05391516744126 | Hemoglobin A1c assay, Ultra2 Affinity HbA1c Analyzer (220V) |