Alere INRatio® 0100139

GUDID M30401001393

INRatio 48 Pack Strips, U.S.

ALERE SAN DIEGO, INC.

Prothrombin time (PT) IVD, kit, clotting

• Primary Device ID: M30401001393
• NIH Device Record Key: a9e6bffe-7d50-464b-b769-4ab9098640d1
• Commercial Distribution Discontinuation: 2017-02-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Alere INRatio®
• Version Model Number: 0100139
• Catalog Number: 0100139
• Company DUNS: 194854949
• Company Name: ALERE SAN DIEGO, 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: 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: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M30401001393 [Primary]

FDA Product Code

• GJS: Test, Time, Prothrombin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-08-23
• Device Publish Date: 2016-10-26

On-Brand Devices [Alere INRatio®]

• M30401001393: INRatio 48 Pack Strips, U.S.
• M30401000713: INRatio 12 Pack Strips, U.S.