Identity
- Trade Name
- MeMed BV® Calibrator FDA UDI
- Generic Name
- Multiple cell-mediated host immune response marker IVD, calibrator FDA UDI
- Model / Reference
- FG11001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17290018739027 FDA UDI
- 510(k) Number
- K210254 FDA UDI
- FDA Product Code
- QPS FDA UDI
- GMDN Term
- Multiple cell-mediated host immune response marker IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3215 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiple cell-mediated host immune response marker IVD, calibrator
MeMed BV® Calibrator by Memed Diagnostics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Memed Diagnostics Ltd
Sources (1)
- FDA UDI 4a5da084-9d25-4e2f-a669-335e30c51ae3 33 fields · synced Jun 1, 2026