Identity
- Trade Name
- Fluorescence Quantitative PCR Detection System FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, point-of-care FDA UDI
- Model / Reference
- MQ4044-4 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975318150034 FDA UDI
- FDA Product Code
- OOI FDA UDI
- GMDN Term
- Thermal cycler nucleic acid amplification analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Thermal cycler nucleic acid amplification analyser IVD, point-of-care
Fluorescence Quantitative PCR Detection System by Anitoa Biotechnology （Hangzhou）Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID
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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
- Anitoa Biotechnology （Hangzhou）Co., Ltd.
Sources (1)
- FDA UDI c122819c-957f-4dd8-848a-eefdbbca559f 32 fields · synced Jun 6, 2026