ARCHITECT Total Beta hCG Controls

ARCHITECT Total Beta hCG Controls
ARCHITECT - 7K78-10

Device Description

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of human chorionic gonadotropin beta-core fragment, a metabolite of human chorionic gonadotropin beta-subunit (beta-HCG), in a clinical specimen.

Environmental Conditions

Handling Environment Humidity - Percent (%) Relative Humidity

0.00
0.00

Handling Environment Temperature - Degrees Celsius

8.00
2.00

Storage Environment Humidity - Percent (%) Relative Humidity

0.00
0.00

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: DHA

Device Name: System, Test, Human Chorionic Gonadotropin

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: 00380740014940

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