Identity
- Trade Name
- Emit® tox™ Acetaminophen Assay FDA UDI
- Generic Name
- Acetaminophen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Emit® tox Acetaminophen Assay labeled with the Beckman Coulter® name FDA UDI
- Model / Reference
- 10445384 FDA UDI
- Description
- Emit® tox Acetaminophen Assay labeled with the Beckman Coulter® name FDA UDI
Identifiers
- Catalog Number
- 7A229 FDA UDI
- Primary DI / UDI-DI
- 00842768023330 FDA UDI
- 510(k) Number
- K002974 FDA UDI
- FDA Product Code
- LDP FDA UDI
- GMDN Term
- Acetaminophen IVD, kit, enzyme immunoassay (EIA) 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
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
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: Acetaminophen IVD, kit, enzyme immunoassay (EIA)
Emit® tox™ Acetaminophen Assay by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acetaminophen IVD, kit, enzyme immunoassay (EIA).
Cleared under the same submission
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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 827f3979-4169-489b-91ac-90ef249d9be0 37 fields · synced May 30, 2026