Identity
- Trade Name
- ADVIA® Chemistry AMY Amylase Reagents FDA UDI
- Generic Name
- Total amylase IVD, kit, spectrophotometry FDA UDI
- Device Name
- Amylase - ADVIA Chem. - RGT - 7x355 tests FDA UDI
- Model / Reference
- 10341130 FDA UDI
- Description
- Amylase - ADVIA Chem. - RGT - 7x355 tests FDA UDI
Identifiers
- Catalog Number
- 3031177 FDA UDI
- Primary DI / UDI-DI
- 00630414517452 FDA UDI
- 510(k) Number
- K991576 FDA UDI
- FDA Product Code
- KHM 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
- 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: Total amylase IVD, kit, spectrophotometry
ADVIA® Chemistry AMY Amylase Reagents by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K991576 also covers:
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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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 0064dea9-7514-40c7-8671-47189bb92a0a 37 fields · synced May 30, 2026