Identity
- Trade Name
- Sickle-Chex FDA UDI
- Generic Name
- Haemoglobin S (HbS) IVD, control FDA UDI
- Device Name
- A positive and negative whole blood control to test for the presence of Hemoglobin S in solubility tests and hemoglobin electrophoresis. Contains 1 each of P+ & N- FDA UDI
- Model / Reference
- 217653 FDA UDI
- Description
- A positive and negative whole blood control to test for the presence of Hemoglobin S in solubility tests and hemoglobin electrophoresis. Contains 1 each of P+ & N- FDA UDI
Identifiers
- Catalog Number
- 217653 FDA UDI
- Primary DI / UDI-DI
- 00844509000884 FDA UDI
- 510(k) Number
- K013316 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
Dimensions & Sizes
- Size
- Total Volume — 2.5 Milliliter FDA UDI
Category: Haemoglobin S (HbS) IVD, control
Sickle-Chex by Streck — Class II — FDA UDI — listed in FDA GUDID — 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
K013316 also covers:
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
- Streck
Sources (1)
- FDA UDI 667bdc81-98f3-48d3-bdb9-ec18312a0cfc 38 fields · synced May 30, 2026