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IDK Extract®

FDA UDI

Class I (US FDA UDI)

by Immundiagnostik, Inc.

Identity

Trade Name
IDK Extract® FDA UDI
Generic Name
Faecal specimen container IVD, transport buffer/medium FDA UDI
Model / Reference
K 6999.17.US FDA UDI

Identifiers

Primary DI / UDI-DI
04050598010512 FDA UDI
FDA Product Code
NNK FDA UDI
GMDN Term
Faecal specimen container IVD, transport buffer/medium FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.3250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Faecal specimen container IVD, transport buffer/medium

IDK Extract® by Immundiagnostik, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Faecal specimen container IVD, transport buffer/medium.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Immundiagnostik, Inc.

Sources (1)

  • FDA UDI f3cda610-f1ac-42c5-ad4e-70121f8229ee 32 fields · synced May 30, 2026