| Primary Device ID | 00860003629901 |
| NIH Device Record Key | db824c8d-c88b-47ab-99e0-6798e4c295d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sickle-Heme |
| Version Model Number | GLD-100 |
| Company DUNS | 804870996 |
| Company Name | GREAT LAKES DIAGNOSTICS, 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 | 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 | 00860003629901 [Primary] |
| GHM | Test, Sickle Cell |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-22 |
| Device Publish Date | 2021-12-13 |
| 00860003629949 | A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human b |
| 00860003629932 | A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human b |
| 00860003629925 | A positive and negative lyophilized whole blood control to test for the presence of Hemoglobin S |
| 00860003629918 | A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human b |
| 00860003629901 | GLD-100 |