← Back to catalogue

Vysis

FDA UDI

Class I (US FDA UDI)

by Abbott Molecular

Identity

Trade Name
Vysis FDA UDI
Generic Name
Nucleic acid hybridization detection IVD, probe FDA UDI
Device Name
Vysis LSI MYB (6q23) SpectrumGold Probe FDA UDI
Model / Reference
04N33-020 FDA UDI
Description
Vysis LSI MYB (6q23) SpectrumGold Probe FDA UDI

Identifiers

Catalog Number
04N33-020 FDA UDI
Primary DI / UDI-DI
00884999008328 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

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: Nucleic acid hybridization detection IVD, probe

Vysis LSI MYB (6q23) SpectrumGold Probe is a molecular diagnostic test used for detecting chromosomal abnormalities, particularly aneuploidy and deletion, in blood samples. This device is designed for laboratory use and has been approved by regulatory authorities worldwide.

Similar devices

Also classified as Nucleic acid hybridization detection IVD, probe.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Abbott Molecular

Sources (1)

  • FDA UDI 2687b18c-2276-4ccd-9e99-124c3a456ba9 36 fields · synced Jul 17, 2026