| Primary Device ID | 00845533002301 |
| NIH Device Record Key | 081e65be-9e03-421b-ba6b-bed08bc9cdd9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Anti-Jo-1 |
| Version Model Number | SM2Z2871G |
| Catalog Number | SM2Z2871G |
| Company DUNS | 080953946 |
| Company Name | ZEUS SCIENTIFIC, 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 | false |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| 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 | 00845533002301 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-17 |
| Device Publish Date | 2025-12-09 |
| 00845533002301 | The Anti-Jo-1 is a semi-quantitative immunoassay for the detection of IgG antibodies to Jo-1 in |
| 00845533002295 | The Anti-Jo-1 is a semi-quantitative immunoassay for the detection of IgG antibodies to Jo-1 in |