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Stak-Chex Plus Retics
FDA 510(k)FDA UDIClass II (US FDA 510(k))
510(k) K090137
by Streck
Identity
- Trade Name
- STaK-Chex Plus Retics FDA UDI
- Generic Name
- Full blood count IVD, control FDA UDI
- Device Name
- A 5-part differential control that monitors all parameters, including reticulocytes and nucleated red blood cells. Contains 4 vials of normal level. FDA UDI
- Model / Reference
- 225481 FDA UDI
- Description
- A 5-part differential control that monitors all parameters, including reticulocytes and nucleated red blood cells. Contains 4 vials of normal level. FDA UDI
Identifiers
- Catalog Number
- 225481 FDA UDI
- Primary DI / UDI-DI
- 20844509000338 FDA UDI
- 510(k) Number
- FDA Product Code
- GLQ FDA 510(k)FDA UDI
- GMDN Term
- Full blood count IVD, control FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 864.8625 FDA 510(k)
- Regulation Number
- 864.8625 FDA 510(k)FDA UDI
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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 — 4.5 Milliliter FDA UDI
Stak-Chex Plus Retics by Streck — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090137 | Class II | Active |
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Manufacturer
- Manufacturer
- Streck
Sources (2)
- FDA 510(k) K090137 24 fields · synced Jun 19, 2026
- FDA UDI cb784478-6f57-456c-afe9-6feafb820c5a 38 fields · synced May 26, 2026