- Physicians Office Resource

STRATIFY JCV™ DXSELECT™ - EL1950

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from JC virus (JCV) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Environmental Conditions

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: OYP

Device Name: Anti-Jcv Antibody Detection Assay

Device Class: 2

Physical State: Reagent kit.

Definition: The anti-jcv antibody detection assay is intended for the detection of antibodies to the john cunningham virus (jcv) in serum or plasma samples from multiple sclerosis (ms) and crohn's disease (cd) patients receiving immunomodulatory therapies.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: A serological test for the detection of the presence on anti-JCV specific antibodies in serum or plasma samples by an enzyme linked immunosorbent technology

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: In-vitro diagnostic test

Regulation Number: 866.3336

Third Party Flag: N

Medical Specialty: MI

Device Identifiers

Device Id: 20816101022254

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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