Identity
- Trade Name
- Amylase / BS480 FDA UDI
- Generic Name
- Total amylase IVD, kit, spectrophotometry FDA UDI
- Device Name
- For the quantitative kinetic determination of a-amylase activity in human serum using the Mindray BS-480 analyzer. 6 x 20 ml FDA UDI
- Model / Reference
- AMY480 FDA UDI
- Description
- For the quantitative kinetic determination of a-amylase activity in human serum using the Mindray BS-480 analyzer. 6 x 20 ml FDA UDI
Identifiers
- Catalog Number
- AMY480 FDA UDI
- Primary DI / UDI-DI
- 00817439020192 FDA UDI
- FDA Product Code
- CIJ FDA UDI
- GMDN Term
- Total amylase IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1070 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Amylase / BS480 by Medtest DX — 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
- Medtest DX
Sources (1)
- FDA UDI ae84a04e-73a4-4aaf-b7f0-a3a748a5dbc6 37 fields · synced Jun 8, 2026