Identity
- Trade Name
- Thermo Scientific Infinity™ FDA UDI
- Generic Name
- Angiotensin converting enzyme (ACE) IVD, calibrator FDA UDI
- Model / Reference
- TR85201 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00845275003444 FDA UDI
- 510(k) Number
- K041657 FDA UDI
- FDA Product Code
- JIS 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Category: Angiotensin converting enzyme (ACE) IVD, calibrator
Thermo Scientific Infinity™ by Fisher Diagnostics — 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 — Sentinel Ch. Srl · Class II
- ACE Calibrator — Analytical Control Systems · Class II
- ACE Calibrator — Sentinel Ch. Srl · Class II
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- ACE Calibrator — Sentinel Ch. Srl · Class II
Cleared under the same submission
K041657 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 II | Pending data |
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Manufacturer
- Manufacturer
- Fisher Diagnostics
Sources (1)
- FDA UDI 728c8c1a-1fcd-431f-82de-1be200419d7e 35 fields · synced Jun 8, 2026