The Access Total BhCG (5th IS) Calibrators are intended to calibrate the Access Total BhCG (5th IS) assay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems.

The Access Total BhCG (5th IS) Calibrators are intended to calibrate the Access Total BhCG (5th IS) assay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems.
Access Total BhCG (5th IS) Calibrators - B11754

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of beta-subunit human chorionic gonadotropin (beta-HCG), which may include free beta-HCG subunit, free nicked beta-HCG subunit and/or beta subunit core fragment, in a clinical specimen using a fluorescent immunoassay method.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JIX

Device Name: Calibrator, Multi-Analyte Mixture

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

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: 862.1150

Third Party Flag: N

Medical Specialty: CH

Device Id: 15099590226220

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