Identity
- Trade Name
- ACE Control Set FDA UDI
- Generic Name
- Angiotensin converting enzyme (ACE) IVD, control FDA UDI
- Device Name
- ACE Control Set is intended to be used with Sentinel ACE Liquid Reagent to monitor the accuracy and precision of the kinetic determination of angiotensin converting enzyme (ACE) assay in human serum or plasma. For In Vitro Diagnostic use. FDA UDI
- Model / Reference
- 1667001 FDA UDI
- Description
- ACE Control Set is intended to be used with Sentinel ACE Liquid Reagent to monitor the accuracy and precision of the kinetic determination of angiotensin converting enzyme (ACE) assay in human serum or plasma. For In Vitro Diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 1667001 FDA UDI
- Primary DI / UDI-DI
- 08058056681775 FDA UDI
- 510(k) Number
- K940272 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Angiotensin converting enzyme (ACE) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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 — 6 Milliliter FDA UDI
Category: Angiotensin converting enzyme (ACE) IVD, control
ACE Control Set by Sentinel Ch. Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Angiotensin converting enzyme (ACE) IVD, control.
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- Trinity Biotech — CLARK LABORATORIES, INC. · Class I
- ACE Elevated Control — Analytical Control Systems · Class I
- ACE Control — Sentinel Ch. Srl · Class I
- ACE Control — Sentinel Ch. Srl · Class I
Cleared under the same submission
K940272 also covers:
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 I | Pending data |
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Manufacturer
- Manufacturer
- Sentinel Ch. Srl
Sources (1)
- FDA UDI c564451e-c5e2-4768-babe-fd2fedd3580e 38 fields · synced May 30, 2026