Identity
- Trade Name
- Acetaminophen Calibrator FDA UDI
- Generic Name
- Acetaminophen IVD, calibrator FDA UDI
- Model / Reference
- 03R7401 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628063401307 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Acetaminophen 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Acetaminophen IVD, calibrator
Acetaminophen Calibrator by Sekisui Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acetaminophen IVD, calibrator.
- Syva® Emit® tox™ Acetaminophen Calibrators — Siemens Healthcare Diagnostics · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- ACET2 calibrator — Roche Diagnostics Corp. · Class II
- Alinity c Acetaminophen Calibrator — Sekisui Diagnostics, LLC · 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
- Sekisui Diagnostics, LLC
Sources (1)
- FDA UDI c94f9574-7f13-42e6-a38f-b44ed020e304 32 fields · synced Jun 9, 2026