AccuDiag ™

Basic Information

• Brand Name: AccuDiag ™
• Primary DI: 00894175000282
• Version / Model: DACD8119-35
• Catalog Number: 8119-35
• Company Name: Diagnostic Automation, Inc.
• Labeler DUNS: 878252071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-06
• Public Version: 1
• Public Version Date: 2024-03-14
• Public Version Status: New
• Public Device Record Key: a955cba5-904a-45a1-b7c0-f9bbe830fd38

Device Description

AccuDiag™ Fasciola IgG ELISA

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: 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
KHW	Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.	Microbiology	866.3220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52231	Fasciola hepatica total 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 total antibodies to the parasitic flatworm Fasciola hepatica 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	00894175000282	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			96 Tests

Storage Conditions

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