The Access Intrinsic Factor Ab Calibrators are intended to calibrate the Access Intrinsic Factor Ab assay for the detection
of intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems.
Access Intrinsic Factor Ab Calibrators - 387993
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to intrinsic factor and/or parietal cells in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis of conditions associated with deficiencies in intrinsic factor and/or parietal cell function/production such as autoimmune gastric disorders (e.g., pernicious anaemia, chronic atrophic gastritis), funicular myelosis, and various autoimmune endocrinopathies.
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: JIT
Device Name: Calibrator, Secondary
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
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: 862.1150
Third Party Flag: N
Medical Specialty: CH
Device Identifiers
Device Id: 15099590229122
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
