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Atellica CH Phny

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Atellica CH Phny FDA UDI
Generic Name
Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry FDA UDI
Device Name
Phenytoin (Phny) Atellica CH - RGT 400T FDA UDI
Model / Reference
11097510 FDA UDI
Description
Phenytoin (Phny) Atellica CH - RGT 400T FDA UDI

Identifiers

Catalog Number
11097510 FDA UDI
Primary DI / UDI-DI
00630414596037 FDA UDI
510(k) Number
K911056 FDA UDI
FDA Product Code
DIP FDA UDI
GMDN Term
Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3350 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: Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

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

Similar devices

Also classified as Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry.

Cleared under the same submission

K911056 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 4fc658ef-5b44-4217-bdd0-453fa331c701 37 fields · synced Jun 8, 2026