Alere INRatio®2 99007G1

GUDID M30499007G11

Boxed Strips, 12-PK., INRatio2 (G1)

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 IDM30499007G11
NIH Device Record Keye664ffd7-a072-4bef-b983-2618b6358f3e
Commercial Distribution Discontinuation2017-02-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAlere INRatio®2
Version Model Number99007G1
Catalog Number99007G1
Company DUNS194854949
Company NameALERE SAN DIEGO, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18773088287
EmailUSproductsupport@alere.com
Phone+18773088287
EmailUSproductsupport@alere.com
Phone+18773088287
EmailUSproductsupport@alere.com
Phone+18773088287
EmailUSproductsupport@alere.com
Phone+18773088287
EmailUSproductsupport@alere.com
Phone+18773088287
EmailUSproductsupport@alere.com
Phone+18773088287
EmailUSproductsupport@alere.com
Phone+18773088287
EmailUSproductsupport@alere.com
Phone+18773088287
EmailUSproductsupport@alere.com
Phone+18773088287
EmailUSproductsupport@alere.com
Phone+18773088287
EmailUSproductsupport@alere.com
Phone+18773088287
EmailUSproductsupport@alere.com
Phone+18773088287
EmailUSproductsupport@alere.com
Phone+18773088287
EmailUSproductsupport@alere.com
Phone+18773088287
EmailUSproductsupport@alere.com
Phone+18773088287
EmailUSproductsupport@alere.com
Phone+18773088287
EmailUSproductsupport@alere.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM30499007G11 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-08-23
Device Publish Date2016-10-26

On-Brand Devices [Alere INRatio®2]

M30499008G11Boxed Strips, 48-PK OUS, INRatio2 (G1)
M30499007G11Boxed Strips, 12-PK., INRatio2 (G1)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.