JAS Diagnostics

Basic Information

• Brand Name: JAS Diagnostics
• Primary DI: 00817274021194
• Version / Model: XL-CHO2-40
• Company Name: DREW SCIENTIFIC, INC.
• Labeler DUNS: 144968104
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 73b88a07-ba30-42f9-98d0-8791d1d5ec16

Device Description

CHOLESTEROL LIQ (5 x 40mL)

Device Characteristics

• Single Use: No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	862.1175	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30222	Total cholesterol lipid IVD, kit, chemiluminescent immunoassay, rapid	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total cholesterol lipid in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a chemiluminescent immunoassay method. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817274021194	GS1

Customer Contacts

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

Storage Conditions

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