The Access Vitamin B12 Calibrators are intended to calibrate the Access Vitamin B12 assay for the quantitative determination of vitamin B12 levels in human serum and plasma (heparin) using the Access Immunoassay Systems.

The Access Vitamin B12 Calibrators are intended to calibrate the Access Vitamin B12 assay for the quantitative determination of vitamin B12 levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
Access Vitamin B12 Calibrators - 33005

A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of vitamin B12 in a clinical specimen.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: CDD

Device Name: Radioassay, Vitamin B12

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: 862.1810

Third Party Flag: Y

Medical Specialty: CH

Device Id: 15099590224325

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