AMA-M2 Screen ELISA

AMA
Immco Diagnostics, Inc. - 5163S

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple antibodies to mitochondria M2 (anti-Mi2) in a clinical specimen, using an enzyme immunoassay (EIA) method.

• 96 determinations

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DBM

Device Name: Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

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: 866.5090

Third Party Flag: Y

Medical Specialty: IM

Device Id: 00845714002526

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