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Atellica CH Phnb

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Atellica CH Phnb FDA UDI
Generic Name
Phenobarbital IVD, kit, nephelometry/turbidimetry FDA UDI
Device Name
Phenobarbital (Phnb) Atellica CH - RGT 400T FDA UDI
Model / Reference
11097514 FDA UDI
Description
Phenobarbital (Phnb) Atellica CH - RGT 400T FDA UDI

Identifiers

Catalog Number
11097514 FDA UDI
Primary DI / UDI-DI
00630414595993 FDA UDI
510(k) Number
K944932 FDA UDI
FDA Product Code
DLZ FDA UDI
GMDN Term
Phenobarbital IVD, kit, nephelometry/turbidimetry 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, nephelometry/turbidimetry

Atellica CH Phnb by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Phenobarbital IVD, kit, nephelometry/turbidimetry.

Cleared under the same submission

K944932 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI f6d72b0c-f669-453e-901d-ff47ad2b456b 37 fields · synced May 30, 2026