Identity
- Trade Name
- Array Card Clip FDA UDI
- Generic Name
- Thermal cycler nucleic acid instrument calibrator/control kit IVD FDA UDI
- Device Name
- VIIA 7 DX ARRAY CARD BUCKET FDA UDI
- Model / Reference
- 4452205 FDA UDI
- Description
- VIIA 7 DX ARRAY CARD BUCKET FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190302007399 FDA UDI
- FDA Product Code
- OUL FDA UDI
- GMDN Term
- Thermal cycler nucleic acid instrument calibrator/control kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2310 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Thermal cycler nucleic acid instrument calibrator/control kit IVD
Array Card Clip by Life Technologies Holdings Pte. 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
- Life Technologies Holdings Pte. Ltd.
Sources (1)
- FDA UDI 9153ff1e-5c3a-4d12-90b3-b2ae6eae48aa 33 fields · synced Jun 8, 2026