JAS Diagnostics

Basic Information

• Brand Name: JAS Diagnostics
• Primary DI: 00817274022696
• Version / Model: ALBS-1L
• Catalog Number: ALBS-1L
• Company Name: DREW SCIENTIFIC, INC.
• Labeler DUNS: 144968104
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-26
• Public Version: 2
• Public Version Date: 2018-07-06
• Public Version Status: New
• Public Device Record Key: 98bccedf-25ab-4489-bded-3dd34b830a11

Device Description

ALBUMIN STANDARD (1x 1L)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: 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
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	862.1035	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53610	Afamin IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of afamin, also known as alpha-albumin (previously known as alpha-1-T glycoprotein) in a clinical specimen, using a nephelometry/turbidimetry method. Afamin has been associated with metabolic syndrome, insulin resistance and ovarian cancer.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817274022696	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K822471	000

Storage Conditions

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