← Back to catalogue

Emit® 2000 Phenobarbital Assay

FDA UDIEUDAMED

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Emit® 2000 Phenobarbital Assay FDA UDI
Generic Name
Phenobarbital IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Emit® 2000 Phenobarbital Assay labeled with the Beckman Coulter® name FDA UDI
Model / Reference
10445308 FDA UDI
Description
Emit® 2000 Phenobarbital Assay labeled with the Beckman Coulter® name FDA UDI

Identifiers

Catalog Number
4D229 FDA UDI
Primary DI / UDI-DI
00842768023224 FDA UDI
510(k) Number
K011528 FDA UDI
FDA Product Code
DLZ FDA UDI
GMDN Term
Phenobarbital IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3660 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: Phenobarbital IVD, kit, enzyme immunoassay (EIA)

Emit® 2000 Phenobarbital Assay by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Phenobarbital IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (2)

  • FDA UDI bb066ff8-7f77-413d-b511-3f314673605d 37 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 18, 2026