JAS Diagnostics

Basic Information

• Brand Name: JAS Diagnostics
• Primary DI: 00817274022795
• Version / Model: MIAC2-7
• Catalog Number: MIAC2-7
• Company Name: DREW SCIENTIFIC, INC.
• Labeler DUNS: 144968104
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-24
• Public Version: 1
• Public Version Date: 2018-08-24
• Public Version Status: New
• Public Device Record Key: 8f8366da-80f1-48dc-b541-fbc55ba0fa67

Device Description

Microalbumin Control Kit (L1 & L2)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• 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
DCF	Albumin, Antigen, Antiserum, Control	Immunology	866.5040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53478	Microalbumin IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of microalbumin in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817274022795	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	14	Milliliter

Storage Conditions

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