Identity
- Trade Name
- SICKLEDEX FDA UDI
- Generic Name
- Haemoglobin S (HbS) IVD, control 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 50 tests. FDA UDI
- Model / Reference
- 217660 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 50 tests. FDA UDI
Identifiers
- Catalog Number
- 217660 FDA UDI
- Primary DI / UDI-DI
- 00844509002031 FDA UDI
- 510(k) Number
- K023656 FDA UDI
- FDA Product Code
- GHM FDA UDI
- GMDN Term
- Haemoglobin S (HbS) IVD, control 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, control
Sickledex by Streck — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Haemoglobin S (HbS) IVD, control.
- Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC. · Class II
- Thermo Scientific Pacific Hemostasis® — Fisher Diagnostics · Class II
- Sickle-Heme — GREAT LAKES DIAGNOSTICS, INC. · Class II
- Dade® Sickle-Trol Hemoglobin Controls — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC. · Class II
- SICKLEDEX — Streck · Class II
- SICKLEDEX — Streck · Class II
- Sickle-Chex — Streck · Class II
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Streck
Sources (2)
- FDA UDI c12297fc-3322-4130-8868-be8e41280d4f 37 fields · synced May 30, 2026
- EUDAMED 1 fields · synced May 24, 2026