| Primary Device ID | 00840239041173 |
| NIH Device Record Key | d192a5b1-d977-424f-b05f-bcd6e6e9a82b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ANA Detect ELISA |
| Version Model Number | EIA-4117 |
| Catalog Number | EIA-4117 |
| Company DUNS | 075150847 |
| Company Name | DRG International 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 | true |
| 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 |
| Phone | 9735647555 |
| corpoffice@drg-international.com | |
| Phone | 9735647555 |
| corpoffice@drg-international.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840239041173 [Primary] |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-04 |
| Device Publish Date | 2023-08-25 |
| 00840239023858 - Free Triiodothyronine (fT3) ELISA | 2024-10-01 For the quantitative determination of Free Triiodothyronine (fT3) concentration in human serum |
| 00840239038012 - Free T3 ELISA | 2024-10-01 The DRG Free T3 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free triiodothyronine (FT |
| 00840239053565 - T3 free | 2024-10-01 The DRG:HYBRiD-XL free T3 is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free Triiodothyronine |
| 00840239038470 - Mumps IgM ELISA | 2024-08-28 The Mumps Virus IgM ELISA is intended for the qualitative determination of IgM class antibodies against Mumps Virus in human ser |
| 00840239056979 - T-3 | 2024-08-21 The DRG:Hybrid-XL T3 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of T3 |
| 00840239035769 - Anti-SS-B ELISA | 2023-10-17 Anti-SS-B ELISA is a test system for the quantitative measurement of IgG class autoantibodies against SS-B (La) in human serum o |
| 00840239048882 - Vitamin C (Ascorbic Acid) | 2023-09-11 This colorimetric microtiter plate assay is suitable for the determination of vitamin C (ascorbic acid) in Li-heparin plasma, se |
| 00084023903579 - Anti-SS-B ELISA | 2023-09-04 Anti-SS-B ELISA is a test system for the quantitative measurement of IgG class autoantibodies against SS-B (La) in human serum o |