For in vitro diagnostics use in the detection of human chorionic gonadotropin (hCG) in urine using the Clinitek Status® analyzer(qualitative)

For in vitro diagnostics use in the detection of human chorionic gonadotropin (hCG) in urine using the Clinitek Status® analyzer(qualitative)
CLINITEST® hCG Pregnancy Test - 10310618

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-) quantitative detection of human chorionic gonadotropin beta-core fragment, a metabolite of human chorionic gonadotropin 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. It is not intended to be used for self-testing.

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: 00630414473604

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