VMA-SKREEN

Basic Information

• Brand Name: VMA-SKREEN
• Primary DI: 00810042682207
• Version / Model: 35070001
• Catalog Number: 35070001
• Company Name: BIOCHEMICAL DIAGNOSTICS INC
• Labeler DUNS: 028007698
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-30
• Public Version: 2
• Public Version Date: 2022-01-11
• Public Version Status: Update
• Public Device Record Key: af1d9ef7-280d-49ba-905a-bd43ff98c711
• Distribution End Date: 2022-01-10

Device Description

VMA SKREEN KIT, 50 Determinations

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: 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
CDF	Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin	Clinical Chemistry	862.1795	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60612	HVA/VMA/5HIAA 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 qquantitative measurement of homovanillic acid (HVA), vanillylmandelic acid (VMA) and 5-hydroxyindoleacetic acid (5HIAA) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810042682207	GS1

Customer Contacts

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

Storage Conditions

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