Neonatal TSH ELISA EIA-1483

GUDID 00840239014832

The DRG Neonatal TSH ELISA kit is specifically designed to quantitate human thyroid stimulating hormone from neonatal blood spot samples collected on Schleicher and Schuell’s filter paper #903.

DRG International Inc

Neonatal thyroid stimulating hormone (neonatal TSH) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00840239014832
• NIH Device Record Key: cc57ebb7-33b0-4dbe-b816-22473c5ec642
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neonatal TSH ELISA
• Version Model Number: EIA-1483
• Catalog Number: EIA-1483
• Company DUNS: 075150847
• Company Name: DRG International 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@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
• 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
• 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	00840239014832 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K912324

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: 2
• Public Version Date: 2020-03-30
• Device Publish Date: 2019-06-10

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