Primary Device ID | 05391516743372 |
NIH Device Record Key | 67e4d748-c9c1-44a7-9630-84923db3ceda |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Trinity Biotech |
Version Model Number | 2325100 |
Catalog Number | 2325100 |
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 | true |
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 |
Device Size Text, specify | 0 |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05391516743372 [Primary] |
LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2020-03-23 |
Device Publish Date | 2016-09-21 |
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) |