Identity
- Trade Name
- Sickle-Heme FDA UDI
- Generic Name
- Haemoglobin S (HbS) IVD, reagent FDA UDI
- Device Name
- A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human blood or sickle cell control material. Contains 250 tests FDA UDI
- Model / Reference
- GLD-250 FDA UDI
- Description
- A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human blood or sickle cell control material. Contains 250 tests FDA UDI
Identifiers
- Catalog Number
- GLD-250 FDA UDI
- Primary DI / UDI-DI
- 00860003629918 FDA UDI
- FDA Product Code
- GHM FDA UDI
- GMDN Term
- Haemoglobin S (HbS) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7825 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Haemoglobin S (HbS) IVD, reagent
Sickle-Heme by Great Lakes Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Great Lakes Diagnostics, Inc.
Sources (1)
- FDA UDI de44a2af-413c-4d72-8bd9-b1e2226b22c0 35 fields · synced May 29, 2026