Identity
- Trade Name
- AMYLASE (CNPG3) Reagent Set FDA UDI
- Generic Name
- Amylase isoenzyme IVD, reagent FDA UDI
- Device Name
- For the quantitative kinetic determination of amylase activity in human serum using a manual or automated procedure. The determination of amylase activity in serum is most commonly performed for the diagnosis and treatment of diseases of the pancreas. FDA UDI
- Model / Reference
- 4 x 120 mL FDA UDI
- Description
- For the quantitative kinetic determination of amylase activity in human serum using a manual or automated procedure. The determination of amylase activity in serum is most commonly performed for the diagnosis and treatment of diseases of the pancreas. FDA UDI
Identifiers
- Catalog Number
- 501-400 FDA UDI
- Primary DI / UDI-DI
- 00812137011879 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
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
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
Category: Amylase isoenzyme IVD, reagent
AMYLASE (CNPG3) Reagent Set by Clinical Diagnostic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Amylase isoenzyme IVD, reagent.
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- AMY — Randox Laboratories, Ltd. · Class II
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- P AMY — Randox Laboratories, Ltd. · Class II
- Thermo Scientific Infinity™ — Fisher Diagnostics · Class II
- 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
- Clinical Diagnostic Solutions, Inc.
Sources (1)
- FDA UDI 89f12aa3-ae3e-418f-9589-1d6fd5f7e91f 36 fields · synced May 30, 2026