Identity
- Trade Name
- ACE FDA UDI
- Generic Name
- Total thyroxine (TT4) IVD, calibrator FDA UDI
- Device Name
- T4 Calibrators FDA UDI
- Model / Reference
- S3-4 FDA UDI
- Description
- T4 Calibrators FDA UDI
Identifiers
- Catalog Number
- S3-4 FDA UDI
- Primary DI / UDI-DI
- 00857969006211 FDA UDI
- FDA Product Code
- JIS FDA UDI
- GMDN Term
- Total thyroxine (TT4) 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
No
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
Category: Total thyroxine (TT4) IVD, calibrator
Ace by Alfa Wassermann, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total thyroxine (TT4) IVD, calibrator.
- Elecsys CalSet T4 — Roche Diagnostics Corp. · Class II
- Alinity — ABBOTT IRELAND · Class II
- Dimension® T4 Calibrator — Siemens Healthcare Diagnostics · Class II
- ARCHITECT — ABBOTT IRELAND · Class I
- ARCHITECT — ABBOTT IRELAND · 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
- Alfa Wassermann, Inc.
Sources (1)
- FDA UDI 0eaa4490-40b6-4521-b99c-c4ab224fedca 36 fields · synced May 30, 2026