Drew Scientific

Basic Information

• Brand Name: Drew Scientific
• Primary DI: 00817274020517
• Version / Model: DSJ-9001-001
• 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: 4
• Public Version Date: 2023-08-03
• Public Version Status: Update
• Public Device Record Key: c795068e-8cc3-4c9a-96e1-e14526350093

Device Description

DS360 HbA1c Analyzer with accessories

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LCP	Assay, Glycosylated Hemoglobin	Hematology	864.7470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56724	Multichannel immunoassay analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple chemical and/or biological markers in a clinical specimen. The analyser typically includes sample processing, requires analyte specific test kits or reagents, and incorporates multiple channels using two or more immunological methods which may include chromatographic or electrochemical separation, together with enzyme, fluorescent, chemiluminescent, nephelometric, radiometric, electrometric and/or photometric detection systems.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817274020517	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 18 – 30 Degrees Celsius