Identity
- Trade Name
- ACE Calibrator FDA UDI
- Generic Name
- Angiotensin converting enzyme (ACE) IVD, calibrator FDA UDI
- Device Name
- ACE Calibrator is intended to be used with ACE Reagent for the calibration of angiotensin converting enzyme (ACE) assay on ARCHITECT c System. Use the CALIBRATOR according to the indicated analytical procedure. For In Vitro Diagnostic use. For laboratory professional use only. FDA UDI
- Model / Reference
- 06U8201 FDA UDI
- Description
- ACE Calibrator is intended to be used with ACE Reagent for the calibration of angiotensin converting enzyme (ACE) assay on ARCHITECT c System. Use the CALIBRATOR according to the indicated analytical procedure. For In Vitro Diagnostic use. For laboratory professional use only. FDA UDI
Identifiers
- Catalog Number
- 06U8201 FDA UDI
- Primary DI / UDI-DI
- 08058056685285 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Angiotensin converting enzyme (ACE) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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, calibrator
ACE Calibrator 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, calibrator.
- ACE Calibrator — Analytical Control Systems · Class II
- Thermo Scientific Infinity™ — Fisher Diagnostics · Class II
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- ACE Calibrator — Sentinel Ch. Srl · Class II
- ACE Calibrator — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sentinel Ch. Srl
Sources (1)
- FDA UDI 9400979f-99e0-4d6d-b1f9-bc0bd326b92b 36 fields · synced Jun 1, 2026