Identity
- Trade Name
- CD-Chex Plus BC FDA UDI
- Generic Name
- Multiple CD cell marker IVD, control FDA UDI
- Device Name
- A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials each of CD4L and Normal level. FDA UDI
- Model / Reference
- 213375 FDA UDI
- Description
- A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials each of CD4L and Normal level. FDA UDI
Identifiers
- Catalog Number
- 213375 FDA UDI
- Primary DI / UDI-DI
- 00844509000532 FDA UDI
- 510(k) Number
- K051633 FDA UDI
- FDA Product Code
- GGL FDA UDI
- GMDN Term
- Multiple CD cell marker IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8625 FDA UDI
- Commercial Distribution
- Not 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
CD-Chex Plus BC by Streck — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K051633 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 2e8b8113-9a6f-4a5e-92ad-47193df4d39b 39 fields · synced May 29, 2026