| Primary Device ID | 05391516746519 |
| NIH Device Record Key | 34530c8e-0aee-4eb6-8ab9-794a8799e47f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Trinity Biotech |
| Version Model Number | 827102 |
| Company DUNS | 623214079 |
| Company Name | CLARK LABORATORIES, INC. |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 1-800-325-3424 |
| customerservice@trinityusa.com |
| Total Volume | 50 Milliliter |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05391516746519 [Primary] |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-06 |
| Device Publish Date | 2019-12-27 |
| 05391516747240 | ACE CONTROL-E |
| 05391516747233 | ACE CONTROL-N |
| 05391516747219 | Captia™ Cytomegalovirus IgM Capture |
| 05391516747202 | Captia™ Legionella pneumophila IgG/IgM |
| 05391516747189 | Captia™ Borrelia burgdorferi IgG/IgM |
| 05391516747172 | Captia™ ENA Combined Screen |
| 05391516747165 | Captia™ Histone |
| 05391516747158 | Captia™ Rheumatoid Factor IgM |
| 05391516747141 | Captia™ ds/DNA |
| 05391516747110 | Captia™ Mumps IgG |
| 05391516747066 | Captia™ Varicella-Zoster Virus (VZV) IgG |
| 05391516747059 | Captia™ Herpes Simplex Virus 2 (HSV 2) IgM |
| 05391516747042 | Captia™ Herpes Simplex Virus 2 (HSV 2) IgG |
| 05391516747035 | Captia™ Herpes Simplex Virus 1 (HSV 1) IgM |
| 05391516747028 | Captia™ Herpes Simplex Virus 1 (HSV1) IgG |
| 05391516747011 | Captia™ Rubella IgM |
| 05391516747004 | Captia™ Rubella IgG |
| 05391516746991 | Captia™ Cytomegalovirus (CMV) IgM |
| 05391516746984 | Captia™ Cytomegalovirus (CMV) IgG |
| 05391516746977 | Captia™ Toxoplasma gondii IgM |
| 05391516746960 | Captia™ Toxoplasma gondii IgG |
| 05391516746939 | Captia™ HSV 2 Type Specific IgG |
| 05391516746922 | Captia™ HSV 1 Type Specific IgG |
| 05391516746496 | Captia™ Herpes Group IgG |
| 05391516746489 | Captia™ Herpes Simplex Virus (HSV) Combined IgM |
| 05391516745147 | Captia™ Malaria EIA |
| 05391516745130 | CAPTIA™ Malaria EIA |
| 05391516745123 | CAPTIA™ Malaria EIA |
| 05391516745109 | CAPTIA™ Syphilis TA EIA |
| 05391516745093 | CAPTIA™ Syphilis TA EIA |
| 05391516745048 | CAPTIA™ NMT Syphilis IgM |
| 05391516745031 | CAPTIA™ CMV TA EIA |
| 05391516745024 | CAPTIA™ CMV TA EIA |
| 05391516744836 | CAPTIA™ Syphilis (T. Pallidum)-G |
| 05391516744829 | CAPTIA™Syphilis (T. Pallidum)-G |
| 05391516744065 | Bartels ELISA Legionella Urinary Antigen |
| 05391516743952 | Captia™ Chlamydia IgG |
| 05391516743938 | Macra® Lp(a) |
| 05391516743914 | Captia™ANA Screen |
| 05391516743891 | Captia™ PR-3 |
| 05391516743877 | Captia™ MPO |
| 05391516743860 | Captia™ ENA Combined Screen |
| 05391516743839 | Captia™ Mitochondria |
| 05391516743822 | Captia™ ENA Profile |
| 05391516743808 | Captia™ Thyroglobulin |
| 05391516743792 | Captia™ Jo-1 |
| 05391516743785 | Captia™ Scl-70 |
| 05391516743778 | Captia™ Sm/RNP |
| 05391516743761 | Captia™ Smith (Sm) |
| 05391516743754 | Captia™ SSB (La) |