Identity
- Trade Name
- CELL-DYN FDA UDI
- Generic Name
- Full blood count IVD, calibrator FDA UDI
- Device Name
- CELL-DYN HemCal Plus Calibrator FDA UDI
- Model / Reference
- 08H57-01 FDA UDI
- Description
- CELL-DYN HemCal Plus Calibrator FDA UDI
Identifiers
- Catalog Number
- 08H5701 FDA UDI
- Primary DI / UDI-DI
- 00380740017071 FDA UDI
- 510(k) Number
- K020469 FDA UDI
- FDA Product Code
- KRY FDA UDIKRX FDA UDIKSA FDA UDIKRZ FDA UDI
- GMDN Term
- Full blood count IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8175 FDA UDI864.8150 FDA UDI864.8185 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
Yes
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
Category: Full blood count IVD, calibrator
Cell-Dyn by Abbott Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Abbott Laboratories, Inc.
Sources (1)
- FDA UDI 2405f097-e3ba-457e-8419-728962cd7182 37 fields · synced May 30, 2026