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Dimension® Flex® reagent cartridge PTN

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension® Flex® reagent cartridge PTN FDA UDI
Generic Name
Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry FDA UDI
Device Name
Phenytoin Flex® reagent cartridge, 112 tests FDA UDI
Model / Reference
10444940 FDA UDI
Description
Phenytoin Flex® reagent cartridge, 112 tests FDA UDI

Identifiers

Catalog Number
DF64 FDA UDI
Primary DI / UDI-DI
00842768005619 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

Dimension® Flex® reagent cartridge PTN 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 fe42aa29-0476-42f8-b77e-db2129f01767 37 fields · synced May 30, 2026