FETAL HEMOGLOBIN
SURE-TECH DIAGNOSTIC ASSOCIATES, INC.
SURE-TECH DIAGNOSTIC ASSOCIATES, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1938095 | 1938095 | SURE-TECH DIAGNOSTIC ASSOCIATES, INC. | 1 | N | 2026-01-01 | 12115 Tesson Ferry Professional Ctr Saint Louis MO US 63128 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 33877 | 1917298870 | K892241 | FETAL HEMOGLOBIN | GHQ | 1989-05-17 |
| 33877 | 1363142445 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GHQ | 1 | 1989-05-17 |
PMN#
GUDID#
ST 201 Fetal Hemoglobin Control - Three level control. Includes TWO 2.0mL vials each level. Plus 20mL saline
2026-05-19
ST 201-B Fetal Hemoglobin Control - Three level control. Includes ONE 2.0mL vials each level. Plus 20mL saline
2026-05-19
ST 201-C Fetal Hemoglobin Control - Three level Control- includes ONE 1.5mL vial each level
2026-05-19
Fetal Hemoglobin Kit - 100 test kit - Kleihauer-Betke Fetal Hemoglobin Test KitIncludes 1 each- 101-10 Red Cell Fixing Solution, 101-20 Citrate Phosphate Buffer, 101-30 Stain Solution
2026-05-15
Fetal Hemoglobin Kit - 200 test kit - Kleihauer-Betke Fetal Hemoglobin Test KitIncludes 2 each- 101-10 Red Cell Fixing Solution, 101-20 Citrate Phosphate Buffer, 101-30 Stain Solution
2026-05-15
Fetal Hemoglobin Test Kit - 300 test kit - Kleihauer-Betke Fetal Hemoglobin Test KitIncludes 3 each- 101-10 Red Cell Fixing Solution, 101-20 Citrate Phosphate Buffer, 101-30 Stain Solution
2026-05-15
Red Cell Fixing Solution - 120mL - 120 mL bottle Red Cell Fixing Solution for Fetal Hemoglobin Test
2026-05-15
Citrate Phosphate Buffer 120 mL - 120 mL bottle Citrate Phosphate Buffer for Fetal Hemoglobin Test
2026-05-15
Hemoglobin Staining Solution - 120 mL Hemoglobin Staining Solution for Fetal Hemoglobin Test
2026-05-15
Red Cell Fixing Solution - 500mL - 500 mL bottle Red Cell Fixing Solution for Fetal Hemoglobin Test
2026-05-15
Citrate Phosphate Buffer 500 mL - 500 mL bottle Citrate Phosphate Buffer for Fetal Hemoglobin Test
2026-05-15
Hemoglobin Staining Solution 500 mL - 500 mL bottle Hemoglobin Staining Solution for Fetal Hemoglobin Test
2026-05-15