VIDAS ® HCG (HCG) assay is a quantitative immunoassay intended for use on VIDAS family instrument in the determination of hCG concentration in human serum or plasma.

VIDAS ® HCG (HCG) assay is a quantitative immunoassay intended for use on VIDAS family instrument in the determination of hCG concentration in human serum or plasma.
VIDAS® HCG - 30405-01

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen using an enzyme immunoassay (EIA) method. It is used to aid detection of pregnancy, or as a predictive indicator of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome).

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 03573026156923

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