QUANTA LITE®Calprotectin Extended Range

Basic Information

• Brand Name: QUANTA LITE®Calprotectin Extended Range
• Primary DI: 08426950913337
• Version / Model: 704860
• Company Name: INOVA DIAGNOSTICS, INC.
• Labeler DUNS: 188354831
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-15
• Public Version: 4
• Public Version Date: 2020-08-21
• Public Version Status: Update
• Public Device Record Key: 2cc97900-7e7a-4a0b-b06f-5de40a55c583

Device Description

1. Antibody coated plate 12x8 wells coated with antibody against calprotectin. Plastic sealed bag containing a desiccant. 2. Enzyme conjugate antibody (IgG) 1 vial containing 15 ml Horse-radish peroxidase-labeled rabbit anti-human calprotectin IgG antibodies in a buffer solution with Proclin 300 as a preservative. Ready-to-use. 3. Substrate 1 vial containing 15 ml substrate reagent (TMB). Ready-to-use 4. Stop Solution 1 vial containing 15 ml H2SO4 (0.5M). Ready-to-use 5. Washing solution (20x) 1 vial containing 50 ml concentrated washing solution. To be diluted with distilled water. 6. Diluent solution (10x) 1 vial containing 20 ml concentrated diluent solution to be diluted with distilled water. 7. Extraction solution (2.5x) 2 vials containing 100 ml concentrated extraction solution to be diluted with distilled water. This concentrated solution is irritating to eyes and skin. 8. Calibrators 6 vials containing 1.5 ml Calprotectin solution at six known concentrations (0, 2.5, 12.5, 25, 50, 150 ng/ml). The value of each Calibrator is printed on the vial label. Ready-to-use. 9. Control 1 1 vial containing 1.5 ml of control 1. Ready-to-use. Do not dilute. The range of values is printed on the vial label. 10. Control 2 1 vial containing 1.5 ml of control 2. Ready-to-use. Do not dilute. The range of values is printed on the vial label.

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
NXO	Calprotectin, Fecal	Immunology	866.5180	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52862	Multiple gastrointestinal disease marker 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 one or multiple antigens or markers associated with gastrointestinal disease in a clinical specimen, using an enzyme immunoassay (EIA) method. Markers to be assayed may include pepsinogen I, pepsinogen II, gastrin and/or antibodies to the bacteria Helicobacter pylori.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426950913337	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K191592	000

Storage Conditions

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