Identity
- Trade Name
- a-Amylase EPS Pancreatic FDA UDI
- Generic Name
- Amylase isoenzyme IVD, kit, spectrophotometry FDA UDI
- Model / Reference
- 08056820190 FDA UDI
Identifiers
- Catalog Number
- 08056820190 FDA UDI
- Primary DI / UDI-DI
- 07613336121016 FDA UDI
- 510(k) Number
- K972250 FDA UDI
- FDA Product Code
- JFJ FDA UDI
- GMDN Term
- Amylase isoenzyme 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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: Amylase isoenzyme IVD, kit, spectrophotometry
a-Amylase EPS Pancreatic by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K972250 also covers:
- Ammonia — Roche Diagnostics Corp.
- Ammonia — Roche Diagnostics Corp.
- Ammonia — Roche Diagnostics Corp.
- Amylase EPS ver2 — Roche Diagnostics Corp.
- Lipase colorimetric assay — Roche Diagnostics Corp.
- Lysergic Acid Diethylamide — Roche Diagnostics Corp.
- ONLINE DAT Lysergic Acid Diethylamide — Roche Diagnostics Corp.
- UREABUN — Roche Diagnostics Corp.
- Urea/Bun — Roche Diagnostics Corp.
- UreaBUN — Roche Diagnostics Corp.
- UreaBUN — Roche Diagnostics Corp.
- a-Amylase EPS ver.2 — Roche Diagnostics Corp.
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
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI c1df94c3-d4fe-473b-b46f-97760d3d85e4 35 fields · synced May 30, 2026