The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, and plasma (heparin) or red blood cells using the Access Immunoassay Systems.

The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, and plasma (heparin) or red blood cells using the Access Immunoassay Systems.
Access Folate - A98032

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of folate (vitamin B9) in a clinical specimen.

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Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: CGN

Device Name: Acid, Folic, Radioimmunoassay

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: 862.1295

Third Party Flag: Y

Medical Specialty: CH

Device Id: 15099590209308

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