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Development Solution

FDA UDI

Class II (US FDA UDI)

by Phadia GmbH

Identity

Trade Name
Development Solution FDA UDI
Generic Name
Plasma protein IVD, reagent FDA UDI
Device Name
Development Solution FDA UDI
Model / Reference
34-2247-36 FDA UDI
Description
Development Solution FDA UDI

Identifiers

Catalog Number
34-2247-36 FDA UDI
Primary DI / UDI-DI
07333066019703 FDA UDI
510(k) Number
K051218 FDA UDI
FDA Product Code
DHB FDA UDI
GMDN Term
Plasma protein IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5750 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

Yes

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: Plasma protein IVD, reagent

Development Solution by Phadia GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Plasma protein IVD, reagent.

Cleared under the same submission

K051218 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Phadia GmbH

Sources (1)

  • FDA UDI 12dc6471-b29d-4848-b5ee-30773eb02e6c 37 fields · synced Jun 6, 2026