The Stratus® CS Acute Care™ Beta human Chorionic Gonadotropin method (ßhCG) is an in vitro diagnostic test for the quantitative measurement of the total beta subunit, vis, both the intact hCG dimer and the free ß subunit, of the human chorionic gonadotropin hormone in heparinized plasma.

The Stratus® CS Acute Care™ Beta human Chorionic Gonadotropin method (ßhCG) is an in vitro diagnostic test for the quantitative measurement of the total beta subunit, vis, both the intact hCG dimer and the free ß subunit, of the human chorionic gonadotropin hormone in heparinized plasma.
Stratus® CS Acute Care™ ßhCG TestPak - 10445060

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

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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

Code: NBC

Device Name: Test, Natriuretic Peptide

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: 862.1117

Third Party Flag: N

Medical Specialty: CH

Code: JIT

Device Name: Calibrator, Secondary

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: 00842768004407

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: 00630414009759

Device Type: Unit of Use

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