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FLEX Mono Mo A-Hu Renal Cell Carcinoma Marker, Cl SPM314, RTU (Dako Omnis)

FDA UDI

Class I (US FDA UDI)

by Agilent Technologies Inc.

Identity

Trade Name
FLEX Mono Mo A-Hu Renal Cell Carcinoma Marker, Cl SPM314, RTU (Dako Omnis) FDA UDI
Generic Name
Renal cell carcinoma antigen IVD, antibody FDA UDI
Device Name
FLEX Monoclonal Mouse Anti-Human Renal Cell Carcinoma Marker, Clone SPM314, Ready-to-Use (Dako Omnis) FDA UDI
Model / Reference
GA075 FDA UDI
Description
FLEX Monoclonal Mouse Anti-Human Renal Cell Carcinoma Marker, Clone SPM314, Ready-to-Use (Dako Omnis) FDA UDI

Identifiers

Primary DI / UDI-DI
05700571107041 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Renal cell carcinoma antigen IVD, antibody 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 — 12 Milliliter FDA UDI

Category: Renal cell carcinoma antigen IVD, antibody

FLEX Mono Mo A-Hu Renal Cell Carcinoma Marker, Cl SPM314, RTU (Dako Omnis) by Agilent Technologies Inc. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Renal cell carcinoma antigen IVD, antibody.

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 8847791a-580a-43a5-b7c4-c10de48ee4a7 36 fields · synced May 30, 2026