Vitamin C (Ascorbic Acid)

Basic Information

• Brand Name: Vitamin C (Ascorbic Acid)
• Primary DI: 00840239048882
• Version / Model: ENZ-4888
• Catalog Number: ENZ-4888
• Company Name: DRG International Inc
• Labeler DUNS: 075150847
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-01
• Public Version: 1
• Public Version Date: 2023-09-11
• Public Version Status: New
• Public Device Record Key: 688c26cf-1427-4845-bc33-054fcc005b7d

Device Description

This colorimetric microtiter plate assay is suitable for the determination of vitamin C (ascorbic acid) in Li-heparin plasma, serum and urine.

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	862.1095	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54463	Vitamin C (ascorbic acid) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of vitamin C (ascorbic acid) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840239048882	GS1

Customer Contacts

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

Storage Conditions

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