The Access Vitamin B12 Calibrator S0 is intended for use with Access Vitamin B12 to dilute patient samples containing analyte concentrations greater than the analyte specic S5 calibrator.
Access Vitamin B12 Calibrator S0 - 33006
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 Identifiers
Device Id: 15099590224318
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