BioPlex 2200 Lyme Total Calibrator CD

BioPlex 2200 Lyme Total Calibrator CD
BioPlex 2200 - 12000878

Device Description

A material used to establish known points of reference for an assay intended for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Borrelia burgdorferi bacteria in a clinical specimen.

Environmental Conditions

No Data Available

Device Sizes

1 Each

1 Each

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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 Identifiers

Device Id: 03610520506417

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