Identity
- Trade Name
- SICKLE CELL FDA UDI
- Generic Name
- Haemoglobin S (HbS) IVD, reagent FDA UDI
- Device Name
- SICKLE CELL (QUALITATIVE Hb-S TEST) FDA UDI
- Model / Reference
- 2243-0 FDA UDI
- Description
- SICKLE CELL (QUALITATIVE Hb-S TEST) FDA UDI
Identifiers
- Catalog Number
- 2243-0 FDA UDI
- Primary DI / UDI-DI
- 00852223007157 FDA UDI
- GMDN Term
- Haemoglobin S (HbS) IVD, reagent FDA UDI
Classification
- 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 Cell by Sterling Diagnostics Inc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemoglobin S (HbS) IVD, reagent.
- Sickle-Heme — GREAT LAKES DIAGNOSTICS, INC. · Class II
- anti-HbS PURE — IQ Products B.V. · Class I
- ASI Sickle Cell Test — Arlington Scientific, Inc. · Class II
- SAS Sickle Cell Test — SA SCIENTIFIC, LTD
- Ritter Dental Implant System — Ritter Implants GmbH CO KG · Class II
- ASI Sickle Cell Test — Arlington Scientific, Inc. · Class II
- Sickle-Heme — GREAT LAKES DIAGNOSTICS, INC. · Class II
- ASI Sickle Cell Test — Arlington Scientific, Inc. · Class II
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sterling Diagnostics Inc
Sources (1)
- FDA UDI 5b3b0f2e-ffd8-4ded-8b07-07eac83c8bb5 34 fields · synced May 31, 2026