Thyroid Stimulating Hormone (TSH) ELISA EIA-1782

GUDID 04048474017823

For the quantitative determination of thyroid stimulating hormone (TSH) concentration in human serum. The assay is useful in the diagnosis of thyroid or pituitary disorders.

DRG Instruments Gesellschaft mit beschränkter Haftung

Multiple thyroid marker IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 04048474017823
• NIH Device Record Key: 1a47c350-c0fb-46c4-9d22-42d4226be2fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thyroid Stimulating Hormone (TSH) ELISA
• Version Model Number: EIA-1782
• Catalog Number: EIA-1782
• Company DUNS: 317134468
• Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung
• 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: true
• 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: 1 973-564-7555
• Email: corpoffice@drg-international.com
• Phone: 1 973-564-7555
• Email: corpoffice@drg-international.com

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	04048474017823 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991146

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: 2023-09-04
• Device Publish Date: 2023-08-26

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