Alere INRatio® 0100071

GUDID M30401000713

INRatio 12 Pack Strips, U.S.

ALERE SAN DIEGO, INC.

Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting Prothrombin time (PT) IVD, kit, clotting

• Primary Device ID: M30401000713
• NIH Device Record Key: 1db296e2-fa5c-4eb9-9d14-989976e8f12f
• Commercial Distribution Discontinuation: 2017-02-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Alere INRatio®
• Version Model Number: 0100071
• Catalog Number: 0100071
• 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	M30401000713 [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.