| Primary Device ID | 04250289512565 |
| NIH Device Record Key | bd06d19b-d516-4986-bffe-d74031a1f4ab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HELMED® AUTOMATED IFA PROCESSOR |
| Version Model Number | REF.HEL-1000 |
| Catalog Number | REF.HEL-1000 |
| Company DUNS | 341714388 |
| Company Name | Aesku.Diagnostics GmbH & Co. KG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 04250289512565 [Primary] |
| JQW | Station, Pipetting And Diluting, For Clinical Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-03 |
| Device Publish Date | 2023-06-25 |
| 04250289512909 - HERA | 2023-07-28 |
| 04250289512541 - HELIOS® AUTOMATED IFA SYSTEM | 2023-07-03 |
| 04250289512565 - HELMED® AUTOMATED IFA PROCESSOR | 2023-07-03 |
| 04250289512565 - HELMED® AUTOMATED IFA PROCESSOR | 2023-07-03 |
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| 04250289500425 - AESKULISA® ANA-8Pro | 2018-07-06 AESKULISA ANA-8Pro is a solid phase enzyme immunoassay for the separate qualitative detection of IgG antibodies against eight ce |
| 04250289500449 - AESKULISA® ENA-6S | 2018-07-06 AESKULISA ENA-6S is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against six cellul |
| 04250289500456 - AESKULISA® ENA-6Pro | 2018-07-06 AESKULISA ENA-6Pro is a solid phase enzyme immunoassay for the separate semiquantitative detection of IgG antibodies against six |
| 04250289500463 - AESKULISA® U1-70 | 2018-07-06 AESKULISA U1-70 is a solid phase enzyme immunoassay employing recombinant human 70 kDa protein of the U1-snRNP complex for the q |