Identity
- Trade Name
- Cell-Chex Auto FDA UDI
- Generic Name
- Full blood count IVD, control FDA UDI
- Device Name
- Spinal and body fluid control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples. Contains 3 vials of level 3. FDA UDI
- Model / Reference
- 200069 FDA UDI
- Description
- Spinal and body fluid control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples. Contains 3 vials of level 3. FDA UDI
Identifiers
- Catalog Number
- 200069 FDA UDI
- Primary DI / UDI-DI
- 20844509000574 FDA UDI
- 510(k) Number
- K053362 FDA UDI
- FDA Product Code
- JPK FDA UDI
- GMDN Term
- Full blood count IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8625 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 — 3.0 Milliliter FDA UDI
Category: Full blood count IVD, control
Cell-Chex Auto by Streck — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K053362 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 4caf8ec4-9c61-4114-a0e3-734690d70f00 38 fields · synced May 29, 2026