QUANTA Lite® aPS/PT IgM ELISA

Basic Information

• Brand Name: QUANTA Lite® aPS/PT IgM ELISA
• Primary DI: 08426950594796
• Version / Model: 708845
• 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: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 4b342d70-96bf-45b6-a11f-0c8d56de87d5

Device Description

(anti-phosphatidylserine and prothrombin) 1. 1 aPS/PT IgM ELISA microwell plate (12-1 x 8 wells), with holder 2. 1 1.2mL prediluted ELISA Negative Control 3. 1 1.2mL prediluted aPS/PT IgM ELISA Control 4. 1 1.2mL prediluted aPS/PT IgM ELISA Calibrator A 5. 1 1.2mL prediluted aPS/PT IgM ELISA Calibrator B 6. 1 1.2mL prediluted aPS/PT IgM ELISA Calibrator C 7. 1 1.2mL prediluted aPS/PT IgM ELISA Calibrator D 8. 1 1.2mL prediluted aPS/PT IgM ELISA Calibrator E 9. 1 10mL HRP aPS/PT IgM Conjugate, (goat), anti-human IgM 10. 1 50mL HRP Sample Diluent Plus 11. 1 25mL HRP Wash Buffer Plus, 40x concentrate 12. 1 10mL TMB Chromogen 13. 1 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
OPN	Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex	Immunology	866.5660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60541	Phosphatidylserine/prothrombin complex 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 one or multiple classes of antibodies to phosphatidylserine/prothrombin complex (PS/PT) in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426950594796	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K090755	000

Storage Conditions

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