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Spark Violet™ 423 anti-human HLA-DR

FDA UDI

Class I (US FDA UDI)

by Biolegend, Inc.

Identity

Trade Name
Spark Violet™ 423 anti-human HLA-DR FDA UDI
Generic Name
Assay development analyte-specific reagent IVD FDA UDI
Device Name
URL: https://www.biolegend.com/en-us/products/spark-violet-423-anti-human-hla-dr-25428 FDA UDI
Model / Reference
980422 FDA UDI
Description
URL: https://www.biolegend.com/en-us/products/spark-violet-423-anti-human-hla-dr-25428 FDA UDI

Identifiers

Catalog Number
980422 FDA UDI
Primary DI / UDI-DI
00810034703569 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Assay development analyte-specific reagent IVD 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

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 500 Microliter FDA UDI

Category: Assay development analyte-specific reagent IVD

Spark Violet™ 423 anti-human HLA-DR by Biolegend, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Assay development analyte-specific reagent IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biolegend, Inc.

Sources (1)

  • FDA UDI 2eb35c32-5e95-42ba-b839-3abd86a02ae1 37 fields · synced May 31, 2026