| Primary Device ID | 04250289504935 |
| NIH Device Record Key | 68b6b153-ddc6-4cef-b0d5-2e34083ae028 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AESKUSLIDES® ANA-HEp-2 gamma |
| Version Model Number | 51.101.US |
| Catalog Number | 51.101.US |
| Company DUNS | 341714388 |
| Company Name | Aesku.Diagnostics GmbH & Co. KG |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04250289504935 [Primary] |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-02-28 |
| 04250289504935 | AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coa |
| 04250289513562 | AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coa |
| 04250289513487 | AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coa |