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Vysis EGR1 FISH Probe Kit (Vysis LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, Spectrum Green Probe), Model 4N37-020

FDA 510(k)

Class II (US FDA 510(k))

510(k) K091960

by Abbott Molecular, Inc.

Identifiers

510(k) Number
K091960 FDA 510(k)
FDA Product Code
OWK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.6040 FDA 510(k)
Regulation Number
866.6040 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Vysis EGR1 FISH Probe Kit is a fluorescence in situ hybridization (FISH) probe kit used for detecting the EGR1 gene region on chromosome 5. The kit contains LSI EGR1 SpectrumOrange probe targeting D5S23 and D5S721, and SpectrumGreen probe for enumeration purposes. This device is designed to identify 5q deletions by analyzing the copy number of the probe targets in cells.

The kit is supplied as a single-use device and is intended for laboratory use. It is not MRI safe and should be stored according to manufacturer instructions. The device has received FDA 510(k) clearance with product code OWK and is classified under regulation number 866.6040. The kit includes model number 4N37-020 and is manufactured by Abbott Molecular, Inc.

Frequently asked questions

What is the Vysis EGR1 FISH Probe Kit used for?

The Vysis EGR1 FISH Probe Kit is a laboratory device used for detecting the EGR1 gene region on chromosome 5 through fluorescence in situ hybridization. It is specifically designed to identify 5q deletions by analyzing the copy number of probe targets in cells.

How is the Vysis EGR1 FISH Probe Kit supplied?

The kit is supplied as a single-use device and contains LSI EGR1 SpectrumOrange probe targeting D5S23 and D5S721, and a SpectrumGreen probe for enumeration purposes. It is intended for laboratory use only.

What are the storage requirements for the Vysis EGR1 FISH Probe Kit?

The kit should be stored according to the manufacturer's instructions. It is not MRI safe, so proper storage conditions must be followed to maintain the integrity of the probes and ensure accurate test results.

What regulatory status does the Vysis EGR1 FISH Probe Kit have?

The Vysis EGR1 FISH Probe Kit has received FDA 510(k) clearance with product code OWK and is classified under regulation number 866.6040. It is manufactured by Abbott Molecular, Inc. and is intended for laboratory use only.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Vysis EGR1 FISH Probe Kit en - molecular.abbott, PDF Vysis EGR1 FISH Probe Kit- SC (Specimen Characterization), Vysis Egr1 Fish Probe Kit (Vysis Lsi Egr1 Spectrum/Orange/D5s23, D5s721 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Abbott Molecular, Inc.

Sources (1)

  • FDA 510(k) K091960 24 fields · synced Oct 6, 2026