Identity
- Trade Name
- ACE Control FDA UDI
- Generic Name
- Angiotensin converting enzyme (ACE) IVD, control FDA UDI
- Device Name
- ACE Control is intended to be used with ACE Reagent to monitor the accuracy and precision of the kinetic determination of angiotensin converting enzyme (ACE) assay in human serum or plasma on Alinity c system. Use the Control material according to the indicated analytical procedure. For In Vitro Diagnostic use. For laboratory professional use only FDA UDI
- Model / Reference
- 06U8610 FDA UDI
- Description
- ACE Control is intended to be used with ACE Reagent to monitor the accuracy and precision of the kinetic determination of angiotensin converting enzyme (ACE) assay in human serum or plasma on Alinity c system. Use the Control material according to the indicated analytical procedure. For In Vitro Diagnostic use. For laboratory professional use only FDA UDI
Identifiers
- Catalog Number
- 06U8610 FDA UDI
- Primary DI / UDI-DI
- 08058056685322 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
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, control
ACE Control by Sentinel Ch. Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Angiotensin converting enzyme (ACE) IVD, control.
- ACE Normal Control — Analytical Control Systems · Class I
- Liquichek — Bio-Rad Laboratories · Class I
- Trinity Biotech — CLARK LABORATORIES, INC. · Class I
- ACE2 Control Slides — BIO SB, INC. · Class I
- Trinity Biotech — CLARK LABORATORIES, INC. · Class I
- ACE Elevated Control — Analytical Control Systems · Class I
- ACE Control Set — Sentinel Ch. Srl · Class I
- ACE Control — Sentinel Ch. Srl · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sentinel Ch. Srl
Sources (1)
- FDA UDI 6fd99342-32ea-430d-9e1f-f21619444e58 36 fields · synced Jun 8, 2026