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 Sentinel ACE Liquid Reagent for the preparation of the calibration for the kinetic determination of angiotensin converting enzyme (ACE) assay in human serum or plasma. For In Vitro Diagnostic use. FDA UDI
- Model / Reference
- 1665001 FDA UDI
- Description
- ACE Calibrator is intended to be used with Sentinel ACE Liquid Reagent for the preparation of the calibration for the kinetic determination of angiotensin converting enzyme (ACE) assay in human serum or plasma. For In Vitro Diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 1665001 FDA UDI
- Primary DI / UDI-DI
- 08058056681768 FDA UDI
- 510(k) Number
- K141728 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
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 — 3 Milliliter 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 |
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Manufacturer
- Manufacturer
- Sentinel Ch. Srl
Sources (1)
- FDA UDI 83c3b330-f06a-4dc4-a2f6-c88063bd002e 38 fields · synced May 30, 2026