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CytoVision GSL 120 Robotics Upgrade for Karyo/ FISH

FDA UDI

Class II (US FDA UDI)

by Leica Biosystems Richmond, Inc.

Identity

Trade Name
CytoVision GSL 120 Robotics Upgrade for Karyo/ FISH FDA UDI
Generic Name
Cell morphology analyser IVD, automated/semi-automated FDA UDI
Device Name
CytoVision GSL 120 Robotics Upgrade for Karyo/ FISH FDA UDI
Model / Reference
23GSL120KFXROB FDA UDI
Description
CytoVision GSL 120 Robotics Upgrade for Karyo/ FISH FDA UDI

Identifiers

Primary DI / UDI-DI
00849832013327 FDA UDI
510(k) Number
K042542 FDA UDI
FDA Product Code
JOY FDA UDI
GMDN Term
Cell morphology analyser IVD, automated/semi-automated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5260 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

CytoVision GSL 120 Robotics Upgrade for Karyo/ FISH by Leica Biosystems Richmond, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K042542 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Leica Biosystems Richmond, Inc.

Sources (1)

  • FDA UDI 5e2a561d-7c80-4de3-ac17-7065412c7945 38 fields · synced May 30, 2026