SimulTRAC-S Vitamin B12/Folate 125I RIA Kit

Basic Information

• Brand Name: SimulTRAC-S Vitamin B12/Folate 125I RIA Kit
• Primary DI: 00817830022603
• Version / Model: 06B254819
• Catalog Number: 06B254819
• Company Name: MP BIOMEDICALS, LLC
• Labeler DUNS: 137825928
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-09
• Public Version: 4
• Public Version Date: 2022-08-05
• Public Version Status: Update
• Public Device Record Key: 5b8f1b0f-bbea-4c3a-8918-17681f3c853c

Device Description

For the cuantitative determination of Vitamin B12 and Folate in Serum or Plasma.

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: 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
CGN	ACID, FOLIC, RADIOIMMUNOASSAY	Clinical Chemistry	862.1295	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54457	Vitamin B12 IVD, kit, radioimmunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of vitamin B12, also known as cobalamin, 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	00817830022603	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K822728	000

Device Sizes

Type	Value	Unit	Text
Length	22.86	Centimeter

Storage Conditions

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