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ORTHO Daily QC Simulated Whole Blood Quality Control Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- ORTHO Daily QC Simulated Whole Blood Quality Control Kit FDA UDI
- Generic Name
- Non-blood cell primer/calibrator/control material IVD, reagent FDA UDI
- Model / Reference
- 6708858 FDA UDI
Identifiers
- Catalog Number
- 6708858 FDA UDI
- Primary DI / UDI-DI
- 04065266566086 FDA UDI
- FDA Product Code
- KSF FDA UDI
- GMDN Term
- Non-blood cell primer/calibrator/control material IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9650 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
No
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: Non-blood cell primer/calibrator/control material IVD, reagent
ORTHO Daily QC Simulated Whole Blood Quality Control Kit by Millipore (u.k.) Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Millipore (u.k.) Limited
Sources (1)
- FDA UDI df6c6067-3ad7-408c-acb2-9f30a7398793 35 fields · synced May 31, 2026