CT hTSH 1000 Tube Kit 07-294106

GUDID 00817830022580

For the quantitative determination of TSH in Serum or Plasma.

MP BIOMEDICALS, LLC

Thyroid stimulating hormone (TSH) IVD, kit, radioimmunoassay

• Primary Device ID: 00817830022580
• NIH Device Record Key: 728f811b-9f69-43ce-8050-c334d06cec3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CT hTSH 1000 Tube Kit
• Version Model Number: 07-294106
• Catalog Number: 07-294106
• 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: 43.18 Centimeter
• Length: 43.18 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	00817830022580 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K865071

FDA Product Code

• JLW: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

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

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• 00817830023082 - MP Biomedicals LLC: 2023-08-10 IMMUCHEM DOUBLE ANTIBODY TOTAL ESTROGENS 125I RIA 500 TUBE KIT
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• 00817830023105 - MP Biomedicals LLC: 2023-08-10 NEONATAL GALACTOSE MW 2 PLATE ENZYME ASSAY KIT (WITH MEMBRANE)