Identity
- Trade Name
- CD-Chex CD34 FDA UDI
- Generic Name
- Multiple CD cell marker IVD, control FDA UDI
- Device Name
- A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 1 vial of level 3. FDA UDI
- Model / Reference
- 213382 FDA UDI
- Description
- A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 1 vial of level 3. FDA UDI
Identifiers
- Catalog Number
- 213382 FDA UDI
- Primary DI / UDI-DI
- 20844509000482 FDA UDI
- 510(k) Number
- K993126 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
- 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 — 1.0 Milliliter FDA UDI
Category: Multiple CD cell marker IVD, control
CD-Chex CD34 by Streck — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K993126 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 5a16729b-04ef-4f7d-b2f0-2ed3ee66a3d6 38 fields · synced May 30, 2026