Identity
- Trade Name
- N Latex CDT Kit FDA UDI
- Generic Name
- Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum on BN II and BN ProSpec® Systems FDA UDI
- Model / Reference
- 10445997 FDA UDI
- Description
- Quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum on BN II and BN ProSpec® Systems FDA UDI
Identifiers
- Catalog Number
- OPCS05 FDA UDI
- Primary DI / UDI-DI
- 00842768018534 FDA UDI
- 510(k) Number
- K060677 FDA UDI
- FDA Product Code
- NAO FDA UDI
- GMDN Term
- Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1360 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry
N Latex CDT Kit by Siemens Healthcare Diagnostics Products Ltd — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 39c7cd6d-557c-4f9c-a637-099c9e9c52f1 37 fields · synced Jun 1, 2026