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Vysis

FDA UDI

Class I (US FDA UDI)

by Abbott Molecular

Identity

Trade Name
Vysis FDA UDI
Generic Name
Chronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe FDA UDI
Device Name
CEP 12 SpectrumOrange FDA UDI
Model / Reference
07J22-012 FDA UDI
Description
CEP 12 SpectrumOrange FDA UDI

Identifiers

Catalog Number
07J22-012 FDA UDI
Primary DI / UDI-DI
00884999027084 FDA UDI
510(k) Number
K962873 FDA UDI
FDA Product Code
KIR FDA UDI
OVQ FDA UDI
GMDN Term
Chronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.2280 FDA UDI
866.6040 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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: Chronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe

Vysis by Abbott Molecular — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Chronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe.

Cleared under the same submission

K962873 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Molecular

Sources (1)

  • FDA UDI 9d51783c-ffa5-49d4-a158-a23796f42378 37 fields · synced Jun 1, 2026