Identity
- Trade Name
- MQC-CAT FDA UDI
- Generic Name
- Non-blood cell primer/calibrator/control material IVD, reagent FDA UDI
- Device Name
- MQC-CAT is intended for the quality control of routine blood bank reagents when tested by CAT techiques. FDA UDI
- Model / Reference
- H9350 FDA UDI
- Description
- MQC-CAT is intended for the quality control of routine blood bank reagents when tested by CAT techiques. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858352006139 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
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: Non-blood cell primer/calibrator/control material IVD, reagent
Mqc-Cat by Hemo Bioscience — 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
- Hemo Bioscience
Sources (1)
- FDA UDI 3212a7ef-a5f4-4563-ac2c-0db5d51ac962 35 fields · synced Jun 8, 2026