- Physicians Office Resource

Zika IgM ADVIA Centaur Quality Control Material Kit 2 x 2 x 2.0 mL
ADVIA Centaur Zika IgM QC - 11202472

Device Description

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Zika virus in a clinical specimen.

Environmental Conditions

Handling Environment Temperature - Degrees Celsius

8.00
2.00

Special Storage Condition, Specify

Store Upright, Protect from Light, Do not freeze, Resuspend

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: QCH

Device Name: Assayed Quality Control Material For Clinical Microbiology Assays

Device Class: 2

Physical State: Liquid or solid

Definition: Serologic controls for microbiology assays

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: For use with serologic microbiology assays

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Not applicable

Regulation Number: 866.3920

Third Party Flag: N

Medical Specialty: MI

Device Identifiers

Device Id: 00630414247014

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

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