Identity
- Trade Name
- Cal-Chex A Plus FDA UDI
- Generic Name
- Full blood count IVD, calibrator FDA UDI
- Device Name
- A hematology calibrator assayed for the Abbott CELL-DYN® 3200, 3500, 3700 and Ruby® analyzers. Contains 1 vial. FDA UDI
- Model / Reference
- 221106 FDA UDI
- Description
- A hematology calibrator assayed for the Abbott CELL-DYN® 3200, 3500, 3700 and Ruby® analyzers. Contains 1 vial. FDA UDI
Identifiers
- Catalog Number
- 221106 FDA UDI
- Primary DI / UDI-DI
- 20844509000314 FDA UDI
- 510(k) Number
- K020469 FDA UDI
- FDA Product Code
- KSA FDA UDIKRY FDA UDIKRX FDA UDIKRZ FDA UDI
- GMDN Term
- Full blood count IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8185 FDA UDI864.8175 FDA UDI864.8150 FDA UDI864.8165 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, calibrator
Cal-Chex A Plus by Streck — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Full blood count IVD, calibrator.
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Cleared under the same submission
K020469 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 19db6030-4a96-4141-841a-79133a1169d6 38 fields · synced May 30, 2026