Thyretain 40-100200.V2

GUDID 30014613331483

THYRETAIN GROWTH MEDIUM

DIAGNOSTIC HYBRIDS, INC.

Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 30014613331483
• NIH Device Record Key: 13b6a37a-e340-4a2e-90b7-dbc01f6484a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thyretain
• Version Model Number: 40-100200.V2
• Catalog Number: 40-100200.V2
• Company DUNS: 117359612
• Company Name: DIAGNOSTIC HYBRIDS, 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(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	30014613331483 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092229

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: 2018-09-24
• Device Publish Date: 2018-08-07

On-Brand Devices [Thyretain]

• 30014613338390: Reaction Buffer
• 30014613338383: GROWTH MEDIUM
• 30014613331681: LUCIFERASE ASSAY SYSTEM
• 30014613331667: TSI MC4 CELLS
• 30014613331636: REFERENCE Control
• 30014613331629: NORMAL SERUM
• 30014613331612: TSI POSITIVE SERUM
• 30014613331605: Thretain TSI Reporter Bioassay 50P
• 30014613331599: THYRETAIN CELL ATTACH SOLUT
• 30014613331582: CELL ATTACHMENT SOLUTION
• 30014613331568: THYRETAIN REACTION BUFFER
• 30014613331544: THYR LUCIFERASE REAGENT SET
• 30014613331537: Thretain TSI Reporter Bioassay 25P
• 30014613331520: THYRETAIN MEDIA SET
• 30014613331513: THYRETAIN CELL AND Control SET
• 30014613331506: THYRETAIN CELLS AND Control SET
• 30014613331490: THYRETAIN CELL & Control SET
• 30014613331483: THYRETAIN GROWTH MEDIUM
• 30014613331476: RSM STARVATION MEDIUM