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Q-STAIN® QSX-Enh-P WT-1

FDA UDI

Class I (US FDA UDI)

by Novodiax, Inc.

Identity

Trade Name
Q-STAIN® QSX-Enh-P WT-1 FDA UDI
Generic Name
Wilms tumour protein IVD, kit, enzyme immunohistochemistry FDA UDI
Device Name
Clone R1012 FDA UDI
Model / Reference
QP32045-004 FDA UDI
Description
Clone R1012 FDA UDI

Identifiers

Catalog Number
QP32045-004 FDA UDI
Primary DI / UDI-DI
00850036867753 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Wilms tumour protein IVD, kit, enzyme immunohistochemistry FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.1860 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 — 4 Milliliter FDA UDI

Category: Wilms tumour protein IVD, kit, enzyme immunohistochemistry

Q-STAIN® QSX-Enh-P WT-1 by Novodiax, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wilms tumour protein IVD, kit, enzyme immunohistochemistry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Novodiax, Inc.

Sources (1)

  • FDA UDI 372ac4c1-c4f1-4317-b7ef-f8262a3014de 37 fields · synced May 30, 2026