Product code GHQ
- Device name
- Stain, Fetal Hemoglobin
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.7455
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00862066000314 | Fetal Hemoglobin Kit - 200 test kit | SURE-TECH DIAGNOSTIC ASSOCIATES, INC. | 2026-05-15 |
| 00862066000321 | Fetal Hemoglobin Test Kit - 300 test kit | SURE-TECH DIAGNOSTIC ASSOCIATES, INC. | 2026-05-15 |
| 00862066000338 | Red Cell Fixing Solution - 120mL | SURE-TECH DIAGNOSTIC ASSOCIATES, INC. | 2026-05-15 |
| 00862066000345 | Citrate Phosphate Buffer 120 mL | SURE-TECH DIAGNOSTIC ASSOCIATES, INC. | 2026-05-15 |
| 00862066000352 | Hemoglobin Staining Solution | SURE-TECH DIAGNOSTIC ASSOCIATES, INC. | 2026-05-15 |
| 00862066000369 | Red Cell Fixing Solution - 500mL | SURE-TECH DIAGNOSTIC ASSOCIATES, INC. | 2026-05-15 |
| 00862066000376 | Citrate Phosphate Buffer 500 mL | SURE-TECH DIAGNOSTIC ASSOCIATES, INC. | 2026-05-15 |
| 00862066000383 | Hemoglobin Staining Solution 500 mL | SURE-TECH DIAGNOSTIC ASSOCIATES, INC. | 2026-05-15 |
| 00862066000307 | Fetal Hemoglobin Kit - 100 test kit | SURE-TECH DIAGNOSTIC ASSOCIATES, INC. | 2026-05-15 |
| 00851318008048 | Simmler, Inc. | SIMMLER INC | 2017-10-19 |
| 00851318008031 | Simmler, Inc. | SIMMLER INC | 2017-10-19 |
| 00851318008024 | Simmler, Inc. | SIMMLER INC | 2017-10-19 |
| 00851318008017 | Simmler, Inc. | SIMMLER INC | 2017-10-19 |
| 00851318008000 | Simmler, Inc. | SIMMLER INC | 2017-10-19 |
| 04054839149092 | Fetal Hemoglobin | Sigma-Aldrich, Inc. | 2016-09-16 |
| 04054839149108 | Fetal Hemoglobin | Sigma-Aldrich, Inc. | 2016-09-16 |
| 10190302005609 | Anti-Human Fetal Hemoglobin R-PE Conjugate | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302005593 | Anti-Human Fetal Hemoglobin R-PE Conjugate | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302005586 | Human Fetal Hemoglobin FITC Conjugate | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302005579 | Human Fetal Hemoglobin FITC Conjugate | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302005340 | Human Fetal Hemoglobin Test Kit | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302005333 | Human Fetal Hemoglobin Test Kit | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |