Identity
- Trade Name
- ACE FDA UDI
- Generic Name
- Acetaminophen IVD, reagent FDA UDI
- Device Name
- The paracetamol test system is intended for the quantitative in vitro determination of Acetaminophen in human serum. FDA UDI
- Model / Reference
- ACE4023 FDA UDI
- Description
- The paracetamol test system is intended for the quantitative in vitro determination of Acetaminophen in human serum. FDA UDI
Identifiers
- Catalog Number
- ACE4023 FDA UDI
- Primary DI / UDI-DI
- 05055273208139 FDA UDI
- 510(k) Number
- K880829 FDA UDI
- FDA Product Code
- LDP FDA UDI
- GMDN Term
- Acetaminophen IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3030 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
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
Category: Acetaminophen IVD, reagent
Ace by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acetaminophen IVD, reagent.
- VITROS — Ortho-Clinical Diagnostics · 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
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 29708875-1ea6-4753-ab3f-b27738814025 37 fields · synced Jun 8, 2026