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Ki-67 IHC MIB-1 pharmDx (Dako Omnis)

FDA UDI

Class III (US FDA UDI)

by Agilent Technologies Inc.

Identity

Trade Name
Ki-67 IHC MIB-1 pharmDx (Dako Omnis) FDA UDI
Generic Name
Ki67 antigen IVD, kit, enzyme immunohistochemistry FDA UDI
Device Name
Ki-67 IHC MIB-1 pharmDx (Dako Omnis) FDA UDI
Model / Reference
GE020 FDA UDI
Description
Ki-67 IHC MIB-1 pharmDx (Dako Omnis) FDA UDI

Identifiers

Primary DI / UDI-DI
05700573004591 FDA UDI
PMA Number
P210026 FDA UDI
FDA Product Code
QQT FDA UDI
GMDN Term
Ki67 antigen IVD, kit, enzyme immunohistochemistry FDA UDI

Classification

Device Class
Class III 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

Yes

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: Ki67 antigen IVD, kit, enzyme immunohistochemistry

Ki-67 IHC MIB-1 pharmDx (Dako Omnis) by Agilent Technologies Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ki67 antigen IVD, kit, enzyme immunohistochemistry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Agilent Technologies Inc.

Sources (1)

  • FDA UDI cf67f102-7090-4bc1-8352-8bb8791f5843 37 fields · synced May 30, 2026