Identity
- Trade Name
- Pancreatic Amylase FDA UDI
- Generic Name
- Amylase isoenzyme IVD, reagent FDA UDI
- Device Name
- The Pancreatic Amylase assay is an in vitro diagnostic test used for the determination on AU480, AU680 and AU5800 automatic analyzers of the pancreatic amylase in serum and plasma by enzymatic colorimetric method. The assay is intended for professional use only. FDA UDI
- Model / Reference
- A53704 FDA UDI
- Description
- The Pancreatic Amylase assay is an in vitro diagnostic test used for the determination on AU480, AU680 and AU5800 automatic analyzers of the pancreatic amylase in serum and plasma by enzymatic colorimetric method. The assay is intended for professional use only. FDA UDI
Identifiers
- Catalog Number
- A53704 FDA UDI
- Primary DI / UDI-DI
- 08058056680587 FDA UDI
- 510(k) Number
- K051447 FDA UDI
- FDA Product Code
- JFJ 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
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
Dimensions & Sizes
- Size
- Total Volume — 102 Milliliter FDA UDI
Category: Amylase isoenzyme IVD, reagent
Pancreatic Amylase by Sentinel Ch. Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- AMY — Randox Laboratories, Ltd. · Class II
- AMY — Randox Laboratories, Ltd. · Class II
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
- Sentinel Ch. Srl
Sources (1)
- FDA UDI aa2db97d-78c3-4073-b329-5978e36c83af 38 fields · synced May 30, 2026