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 |
Phone | +18773088287 |
USproductsupport@alere.com | |
Phone | +18773088287 |
USproductsupport@alere.com | |
Phone | +18773088287 |
USproductsupport@alere.com | |
Phone | +18773088287 |
USproductsupport@alere.com | |
Phone | +18773088287 |
USproductsupport@alere.com | |
Phone | +18773088287 |
USproductsupport@alere.com | |
Phone | +18773088287 |
USproductsupport@alere.com | |
Phone | +18773088287 |
USproductsupport@alere.com | |
Phone | +18773088287 |
USproductsupport@alere.com | |
Phone | +18773088287 |
USproductsupport@alere.com | |
Phone | +18773088287 |
USproductsupport@alere.com | |
Phone | +18773088287 |
USproductsupport@alere.com | |
Phone | +18773088287 |
USproductsupport@alere.com | |
Phone | +18773088287 |
USproductsupport@alere.com | |
Phone | +18773088287 |
USproductsupport@alere.com | |
Phone | +18773088287 |
USproductsupport@alere.com | |
Phone | +18773088287 |
USproductsupport@alere.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M30401001393 [Primary] |
GJS | Test, Time, Prothrombin |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2023-08-23 |
Device Publish Date | 2016-10-26 |
M30401001393 | INRatio 48 Pack Strips, U.S. |
M30401000713 | INRatio 12 Pack Strips, U.S. |