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FAST 96-Well Region of Interest (ROI) and Background Plates
EUDAMEDFDA UDIClass A (EU MDR)
Ref 4432638
Identity
- Trade Name
- FAST 96-Well Region of Interest (ROI) and Background Plates EUDAMEDFDA UDI
- Generic Name
- Thermal cycler nucleic acid instrument calibrator/control kit IVD FDA UDI
- Device Name
- Region of Interest (ROI) and Background Plates, a part of Calibration and Verification Plates EUDAMEDFAST 96W ROI AND BACKGND IVD FDA UDI
- Model / Reference
- 4432638 EUDAMEDFDA UDI
- Description
- FAST 96W ROI AND BACKGND IVD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190302000437 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190302TCF0000576AAK EUDAMED
- 510(k) Number
- K123955 FDA UDI
- FDA Product Code
- OOI FDA UDI
- EMDN Code
- W02050199 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER EUDAMED
- GMDN Term
- Thermal cycler nucleic acid instrument calibrator/control kit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.2570 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
FAST 96-Well Region of Interest (ROI) and Background Plates by Life Technologies Holdings Pte Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0190302TCF0000576AAK | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Life Technologies Holdings Pte Ltd
- EUDAMED SRN
- SG-MF-000023931
- Authorised Representative
- Life Technologies Europe B.V. NL-AR-000021890
Sources (2)
- EUDAMED 70131d28-64c3-4d3f-a4b1-ca91bf99ad8e 61 fields · synced Oct 6, 2026
- FDA UDI 4b1032ff-df6b-41df-bfe9-610c3875c0f5 34 fields · synced May 30, 2026