Anti TPO Ab ELISA EIA-3561

GUDID 04048474035612

Anti TPO Ab ELISA is a test system for the quantitative measurement of IgG class autoantibodies against thyroid peroxidase (TPO) in human serum or plasma.

DRG Instruments Gesellschaft mit beschränkter Haftung

Thyroglobulin/Thyroid peroxidase antibody (anti-TPO/Microsomal antibody) IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid autoantibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid autoantibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid autoantibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid autoantibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid autoantibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid autoantibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid autoantibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid autoantibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid autoantibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid autoantibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid autoantibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid autoantibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid autoantibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid autoantibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid autoantibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid autoantibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid autoantibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid autoantibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid autoantibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid autoantibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid autoantibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid autoantibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA) Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 04048474035612
• NIH Device Record Key: ab68a351-e928-4f5c-9bcc-9466d9606d60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anti TPO Ab ELISA
• Version Model Number: EIA-3561
• Catalog Number: EIA-3561
• 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: 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
• 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
• 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
• 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
• 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
• 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
• 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	04048474035612 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K952129

FDA Product Code

• JZO: SYSTEM, TEST, THYROID AUTOANTIBODY

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

On-Brand Devices [Anti TPO Ab ELISA]

• 00404847435610: Anti TPO Ab ELISA is a test system for the quantitative measurement of IgG class autoantibodies
• 04048474035612: Anti TPO Ab ELISA is a test system for the quantitative measurement of IgG class autoantibodies