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Kreatech FISH probes

FDA UDI

Class I (US FDA UDI)

by Kreatech Biotechnology B.V.

Identity

Trade Name
Kreatech FISH probes FDA UDI
Generic Name
Nucleic acid hybridization detection IVD, probe FDA UDI
Model / Reference
05P001I495 FDA UDI

Identifiers

Primary DI / UDI-DI
08718858480685 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Nucleic acid hybridization detection IVD, probe FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4020 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Nucleic acid hybridization detection IVD, probe

The Kreatech FISH probes medical device is a nucleic acid hybridization detection instrument designed for use in clinical settings to identify chromosomal abnormalities. It features high-resolution imaging and provides accurate results for various diseases, including aneuploidy, deletion, translocation, duplication, inversion, gene insertion, and more.

Similar devices

Also classified as Nucleic acid hybridization detection IVD, probe.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kreatech Biotechnology B.V.

Sources (1)

  • FDA UDI 8e516d92-3e2d-41f6-ab41-bfa953e3f48a 35 fields · synced Jul 21, 2026