- Physicians Office Resource

QkVue hCG Urine 25T
QuickVue - One-Step hCG Urine Test

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of the beta subunit on the intact HCG hormone and/or free beta subunit (beta-HCG) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses for early detection of pregnancy, as a predictive indicator of adverse pregnancy outcomes (e.g., miscarriage), or as an indicator of trisomy 21 (Down syndrome) during pregnancy. It is not intended to be used for self-testing.

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: 30014613201090

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

Device Id: 50014613201940

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 30014613201090

Package Quantity: 12

Package Discontinue Date: 12/4/2025 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Case

Device Id: 50014613201094

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 30014613201090

Package Quantity: 12

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

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