| Primary Device ID | 07340058410196 |
| NIH Device Record Key | 7253faba-9217-48cf-9b72-febd9d60236a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DIASTAT anti-Cardiolipin IgG |
| Version Model Number | FCAR100G |
| Catalog Number | FCAR100G |
| Company DUNS | 559894501 |
| Company Name | Euro-Diagnostica AB |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07340058410196 [Primary] |
| MID | System, Test, Anticardiolipin Immunological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-12 |
| 07340058410004 - DIASTAT anti-Ro (SS-A) | 2018-07-06 |
| 07340058410011 - DIASTAT anti-La (SS-B) | 2018-07-06 |
| 07340058410035 - DIASTAT anti-dsDNA | 2018-07-06 |
| 07340058410059 - DIASTST anti-Sm | 2018-07-06 |
| 07340058410110 - DIASTAT anti-thyroglobulin | 2018-07-06 |
| 07340058410134 - DIASTAT anti-Thyroid Peroxidase | 2018-07-06 |
| 07340058410417 - DIASTAT anti-Mitochondrial | 2018-07-06 |
| 07340058410431 - CCPoint | 2018-07-06 |