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VENTANA ANTI-MLH1 (M1) Mouse Monoclonal Primary Antibody

FDA UDI

Class III (US FDA UDI)

by Ventana Medical Systems

Identity

Trade Name
VENTANA ANTI-MLH1 (M1) Mouse Monoclonal Primary Antibody FDA UDI
Generic Name
Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent FDA UDI
Device Name
MMR IHC Panel Antibody FDA UDI
Model / Reference
790-5091 FDA UDI
Description
MMR IHC Panel Antibody FDA UDI

Identifiers

Catalog Number
07862237001 FDA UDI
Primary DI / UDI-DI
07613336100561 FDA UDI
PMA Number
P200019 FDA UDI
P210001 FDA UDI
510(k) Number
DEN170030 FDA UDI
FDA Product Code
QNH FDA UDI
PZJ FDA UDI
GMDN Term
Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
864.1860 FDA UDI
864.1866 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

Yes

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

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: Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagentMLH1 protein IVD, antibody

VENTANA ANTI-MLH1 (M1) Mouse Monoclonal Primary Antibody by Ventana Medical Systems — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as MLH1 protein IVD, antibody.

Cleared under the same submission

DEN170030 also covers:

P200019 also covers:

P210001 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ventana Medical Systems

Sources (1)

  • FDA UDI a7ad46e9-36df-4f43-9557-72b8f52afe4a 35 fields · synced May 31, 2026