Identity
- Trade Name
- ACE Reagent FDA UDI
- Generic Name
- Angiotensin converting enzyme (ACE) IVD, reagent FDA UDI
- Device Name
- The ACE Reagent is an automated assay intended for in vitro diagnostic use in the quantitative determination of angiotensin converting enzyme (ACE) activity in human serum or plasma on the Alinity c system. This test is used as an aid in the diagnosis of pulmonary sarcoidosis and other pathologic conditions involving lung and liver diseases. For laboratory professional use only. FDA UDI
- Model / Reference
- 06U8625 FDA UDI
- Description
- The ACE Reagent is an automated assay intended for in vitro diagnostic use in the quantitative determination of angiotensin converting enzyme (ACE) activity in human serum or plasma on the Alinity c system. This test is used as an aid in the diagnosis of pulmonary sarcoidosis and other pathologic conditions involving lung and liver diseases. For laboratory professional use only. FDA UDI
Identifiers
- Catalog Number
- 06U8625 FDA UDI
- Primary DI / UDI-DI
- 08058056685339 FDA UDI
- FDA Product Code
- KQN FDA UDI
- GMDN Term
- Angiotensin converting enzyme (ACE) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1090 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Angiotensin converting enzyme (ACE) IVD, reagent
ACE Reagent by Sentinel Ch. Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Angiotensin converting enzyme (ACE) IVD, reagent.
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- ACE Kinetic Kit — Bühlmann Laboratories AG · Class II
- ACE Kinetik Kit — Bühlmann Laboratories AG · Class II
- ACE Liquid — Sentinel Ch. Srl · Class II
- ACE Reagent — Sentinel Ch. Srl · 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 cc5c0aa9-7ffe-49c1-ac80-3b1197072898 36 fields · synced Jun 6, 2026