MP Biomedicals LLC

Basic Information

• Brand Name: MP Biomedicals LLC
• Primary DI: 00817830023129
• Version / Model: 07553306
• Catalog Number: 07553306
• Company Name: Mp Biomedicals, LLC
• Labeler DUNS: 614875644
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-02
• Public Version: 1
• Public Version Date: 2023-08-10
• Public Version Status: New
• Public Device Record Key: dd53e747-64a0-46da-a91f-8762c1dbf672

Device Description

NEONATAL GALACTOSE MW 10 PLATE ENZYME ASSAY KIT (WITH MEMBRANE)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• 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
JIA	Enzymatic Methods, Galactose	Clinical Chemistry	862.1310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59373	Galactose IVD, kit, enzyme fluorescence	A collection of reagents and other associated materials intended to be used for the quantitative measurement of galactose in a clinical specimen, using an enzyme fluorescence method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817830023129	GS1

Premarket Submissions

Submission Number	Supplement Number
K951329	000