QUANTA Lite® Intrinsic Factor ELISA

Basic Information

• Brand Name: QUANTA Lite® Intrinsic Factor ELISA
• Primary DI: 08426950454526
• Version / Model: 708780
• Company Name: INOVA DIAGNOSTICS, INC.
• Labeler DUNS: 188354831
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 4
• Public Version Date: 2021-06-08
• Public Version Status: Update
• Public Device Record Key: 00526904-916f-4f65-aa26-9dd9ac26d2f5

Device Description

1.1x Intrinsic Factor ELISA microwell plate, (12-1 x 8 wells), with holder 2.1x 1.2mL prediluted ELISA Negative Control 3.1x1.2mL prediluted Intrinsic Factor ELISA Low Positive 4.1x 1.2mL prediluted Intrinsic Factor ELISA High Positive 5.1x 50mL HRP Sample Diluent 6.1x 25mL HRP Wash Concentrate, 40x concentrate 7.1x 10mL HRP IgG Conjugate, (goat) 8.1x 10mL TMB Chromogen 9.1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LIG	Radioassay, Intrinsic Factor Blocking Antibody	Clinical Chemistry	862.1810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54986	Intrinsic factor/parietal cell antibody IVD, kit, enzyme immunoassay (EIA)	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426950454526	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K061841	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius