ARCHITECT Anti-TPO Reagent Kit

ARCHITECT Anti
ARCHITECT - 2K47-27

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to thyroid peroxidase [anti-TPO, also known as anti-microsomal antibody] in a clinical specimen, using a chemiluminescent immunoassay method. It is typically used to aid in the diagnosis of chronic lymphocytic thyroiditis (also known as hashimoto thyroiditis).

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JZO

Device Name: System, Test, Thyroid Autoantibody

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: IM

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: 866.5870

Third Party Flag: Y

Medical Specialty: IM

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

Code: JJX

Device Name: Single (Specified) Analyte Controls (Assayed And Unassayed)

Device Class: 1

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: 862.1660

Third Party Flag: N

Medical Specialty: CH

Device Id: 00380740048327

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