SimulTRAC-S Vitamin B12/Folate 125I RIA Kit 06B254819

GUDID 00817830022603

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

MP BIOMEDICALS, LLC

Vitamin B12 IVD, kit, radioimmunoassay

• Primary Device ID: 00817830022603
• NIH Device Record Key: 5b8f1b0f-bbea-4c3a-8918-17681f3c853c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SimulTRAC-S Vitamin B12/Folate 125I RIA Kit
• Version Model Number: 06B254819
• Catalog Number: 06B254819
• Company DUNS: 137825928
• Company Name: MP BIOMEDICALS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com
• Phone: +1(800)854-0530
• Email: custserv@mpbio.com

Device Dimensions

• Length: 22.86 Centimeter
• Length: 22.86 Centimeter
• Length: 22.86 Centimeter
• Length: 22.86 Centimeter
• Length: 22.86 Centimeter
• Length: 22.86 Centimeter
• Length: 22.86 Centimeter
• Length: 22.86 Centimeter
• Length: 22.86 Centimeter
• Length: 22.86 Centimeter
• Length: 22.86 Centimeter
• Length: 22.86 Centimeter
• Length: 22.86 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817830022603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K822728

FDA Product Code

• CGN: ACID, FOLIC, RADIOIMMUNOASSAY

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-09

On-Brand Devices [SimulTRAC-S Vitamin B12/Folate 125I RIA Kit]

• 00817830022603: For the cuantitative determination of Vitamin B12 and Folate in Serum or Plasma.
• 00817830022542: Radioimmunoassay for the quantitative determination of Vitamin B12/Folate in human plasma or ser