BioCheck U-TSH EIA Test Kit BC-1003

GUDID 00850392007039

The BioCheck U-TSH EIA Test Kit is intended for the quantitative determination of thyroid stimulating hormone (TSH) concentration in human serum.

BIOCHECK, INC.

Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00850392007039
• NIH Device Record Key: 0cf10fd3-a00f-4bf6-a22f-179ab9ac5eca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioCheck U-TSH EIA Test Kit
• Version Model Number: BC-1003
• Catalog Number: BC-1003
• Company DUNS: 171857493
• Company Name: BIOCHECK, INC.
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (650)573-1968
• Email: info@biocheckinc.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850392007039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990993

FDA Product Code

• JLW: Radioimmunoassay, Thyroid-Stimulating Hormone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-16
• Device Publish Date: 2019-10-08

Devices Manufactured by BIOCHECK, INC.

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• 00850392007039 - BioCheck U-TSH EIA Test Kit: 2019-10-16The BioCheck U-TSH EIA Test Kit is intended for the quantitative determination of thyroid stimulating hormone (TSH) concentration in human serum.
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