MedTest DX Homocysteine Controls

Basic Information

• Brand Name: MedTest DX Homocysteine Controls
• Primary DI: 00817439020925
• Version / Model: HOMQ480
• Catalog Number: HOMQ480
• Company Name: Medtest Dx, Inc.
• Labeler DUNS: 070371210
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-30
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 3cbff80d-1a5b-40d8-918a-c70db58275d5

Device Description

The Homocysteine Control Kit is intended to be used as an assayed quality control serum when used for the quantitative measurement of total Lhomocysteine in human serum or plasma. Size: 6 x 1.5ml

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: No
• 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
LPS	Urinary Homocystine (Nonquantitative) Test System	Clinical Chemistry	862.1377	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53750	Homocysteine IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of homocysteine in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817439020925	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K980907	000

Storage Conditions

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