QkVue HCG Combo, 50T


Product Overview

QkVue HCG Combo, 50T
QuickVue - One-Step hCG Combo Test


Device Description

One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of the beta subunit on the intact HCG hormone and/or free beta subunit (beta-HCG) in a clinical specimen.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: JHI

Device Name: Visual, Pregnancy Hcg, Prescription Use

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.1155

Third Party Flag: Y

Medical Specialty: CH


Device Identifiers

Device Id: 30014613201106

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


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