Identity
- Trade Name
- ClearChem Diagnostics Inc. Amylase FDA UDI
- Generic Name
- Amylase isoenzyme IVD, reagent FDA UDI
- Device Name
- In Vitro Diagnostics testing kit R1:3X60mL FDA UDI
- Model / Reference
- AMY1030 FDA UDI
- Description
- In Vitro Diagnostics testing kit R1:3X60mL FDA UDI
Identifiers
- Catalog Number
- AMY1030 FDA UDI
- Primary DI / UDI-DI
- 00852169008041 FDA UDI
- FDA Product Code
- CIJ FDA UDI
- GMDN Term
- Amylase isoenzyme IVD, reagent 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Dimensions & Sizes
- Size
- Total Volume — 180 Milliliter FDA UDI
Category: Amylase isoenzyme IVD, reagent
ClearChem Diagnostics Inc. Amylase by Clearchem Diagnostics Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Clearchem Diagnostics Inc.
Sources (1)
- FDA UDI 3c2a5360-db65-4a21-80c6-535a2be5b807 37 fields · synced May 30, 2026