Autoimmune EIA

Basic Information

• Brand Name: Autoimmune EIA
• Primary DI: 00847817006937
• Version / Model: 220HDS
• Catalog Number: 220HDS
• Company Name: BIO-RAD LABORATORIES, INC.
• Labeler DUNS: 884513334
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 5
• Public Version Date: 2021-07-29
• Public Version Status: Update
• Public Device Record Key: c5f9aaf6-52dd-4b15-b64f-da9ce0b9ee11

Device Description

Autoimmune EIA DNA Conjugate, 15 mL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• 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
54904	Double stranded DNA antibody (anti-dsDNA) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antibodies to double stranded DNA (anti-dsDNA) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847817006937	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K960091	000

Device Sizes

Type	Value	Unit	Text
Total Volume	15	Milliliter

Storage Conditions

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