| Device Type ID | 2274 |
| Device Name | Stain, Fetal Hemoglobin |
| Regulation Description | Fetal Hemoglobin Assay. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 864.7455 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GHQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 2274 |
| Device | Stain, Fetal Hemoglobin |
| Product Code | GHQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Fetal Hemoglobin Assay. |
| CFR Regulation Number | 864.7455 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Life Technologies Corporation | II | Apr-17-2018 |