AccuDiag ™

Basic Information

• Brand Name: AccuDiag ™
• Primary DI: 00850049545242
• Version / Model: DACD6101-15
• Catalog Number: 6101-15
• Company Name: Diagnostic Automation, Inc.
• Labeler DUNS: 878252071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-30
• Public Version: 1
• Public Version Date: 2024-02-07
• Public Version Status: New
• Public Device Record Key: 6e0843b6-b925-4011-96ec-295571570228

Device Description

AccuDiag ™ Cortisol ELISA kit is intended for the Quantitative determination of Total Cortisol concentration in human serum or plasma.

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
CGR	Radioimmunoassay, Cortisol	Clinical Chemistry	862.1205	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62281	Total cortisol 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 cortisol in a clinical specimen, using an enzyme immunoassay (EIA) method. It is used as an aid in the diagnosis and treatment of adrenal disorders.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850049545242	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 Humidity
• Temperature Range: 2 – 8 Degrees Celsius