Conjugated Bile Acids 125I RIA Kit 06B242918

GUDID 00817830022290

Radioimmunoassay for the quantitative determination of conjugated bile acids in human serum or plasma.

MP BIOMEDICALS, LLC

Conjugated sulfalithocholic acid (SLCG) IVD, kit, radioimmunoassay

• Primary Device ID: 00817830022290
• NIH Device Record Key: 865855f9-c6af-43c6-9806-ca5fc22ee5ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Conjugated Bile Acids 125I RIA Kit
• Version Model Number: 06B242918
• Catalog Number: 06B242918
• 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

Device Dimensions

• Length: 28 Centimeter
• Length: 28 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817830022290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K781337

FDA Product Code

• KWW: RADIOIMMUNOASSAY, CHOLYGLYCINE, BILE ACIDS

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: 2016-10-20

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• 00817830023105 - MP Biomedicals LLC: 2023-08-10 NEONATAL GALACTOSE MW 2 PLATE ENZYME ASSAY KIT (WITH MEMBRANE)