MP Biomedicals LLC

Basic Information

• Brand Name: MP Biomedicals LLC
• Primary DI: 00817830023211
• Version / Model: 07189105
• Catalog Number: 07189105
• Company Name: Mp Biomedicals, LLC
• Labeler DUNS: 614875644
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-03
• Public Version: 1
• Public Version Date: 2023-08-11
• Public Version Status: New
• Public Device Record Key: c091262f-acf8-4ac8-91a1-82dd1ec6b7ad

Device Description

IMMUCHEM DOUBLE ANTIBODY TESTOSTERONE 125I 500 TUBE KIT

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
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	862.1680	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58377	Total testosterone IVD, kit, radioimmunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total testosterone in a clinical specimen, using a radioimmunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817830023211	GS1

Premarket Submissions

Submission Number	Supplement Number
K791999	000