Autoimmune EIA

Basic Information

• Brand Name: Autoimmune EIA
• Primary DI: 00847817022340
• Version / Model: 96CE
• Catalog Number: 96CE
• 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: fbdf566b-7313-4c69-9078-ed6cd8e26e26

Device Description

Autoimmune EIA Anti-Centromere Test

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
LLL	EXTRACTABLE ANTINUCLEAR ANTIBODY, ANTIGEN AND CONTROL	Immunology	866.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54886	Centromere 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 anticentromere antibodies 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	00847817022340	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K000489	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			96 Tests

Storage Conditions

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