SeraQuest

Basic Information

• Brand Name: SeraQuest
• Primary DI: 00850487007449
• Version / Model: Anti-dsDNA
• Catalog Number: Q01-210
• Company Name: QUEST INTERNATIONAL, INC.
• Labeler DUNS: 883350811
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 1d0604a5-0526-485b-846e-20892d34e7e6

Device Description

Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)

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
LRM	Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control	Immunology	866.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54902	Double stranded DNA antibody (anti-dsDNA) 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 double stranded DNA (anti-dsDNA) 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	00850487007449	GS1

Storage Conditions

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