| Primary Device ID | 04260157632158 |
| NIH Device Record Key | eb7e46bf-decb-4df1-a19a-779de137c009 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | B.R.A.H.M.S sFlt-1 KRYPTOR |
| Version Model Number | 845075N |
| Company DUNS | 343844205 |
| Company Name | B.R.A.H.M.S GmbH |
| 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 | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260157632158 [Primary] |
| QWH | Prognostic Test For Development Or Progression Of Preeclampsia |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-30 |
| Device Publish Date | 2023-05-22 |
| 04260157632127 - B.R.A.H.M.S CgA II KRYPTOR | 2023-10-02 |
| 04260157632288 - B.R.A.H.M.S CgA II KRYPTOR CAL | 2023-06-28 |
| 04260157632295 - B.R.A.H.M.S CgA II KRYPTOR QC | 2023-06-28 |
| 04260157632158 - B.R.A.H.M.S sFlt-1 KRYPTOR | 2023-05-30 |
| 04260157632158 - B.R.A.H.M.S sFlt-1 KRYPTOR | 2023-05-30 |
| 04260157632196 - B.R.A.H.M.S PlGF plus KRYPTOR | 2023-05-30 |
| 04260157632455 - B.R.A.H.M.S PlGF plus KRYPTOR CAL | 2023-05-29 |
| 04260157632462 - B.R.A.H.M.S PlGF plus KRYPTOR QC | 2023-05-29 |
| 04260157632479 - B.R.A.H.M.S sFlt-1 KRYPTOR CAL | 2023-05-29 |