25-OH Vitamin D Assay Protocol File CD, SW4.2_v3, US

25
BioPlex 2200 - SW4.2 V3

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy vitamin D in a clinical specimen, using a chemiluminescent immunoassay.

No Data Available

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Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MRG

Device Name: System, Test, Vitamin D

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 862.1825

Third Party Flag: Y

Medical Specialty: CH

Device Id: 03610520506349

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