FDA.reportPublic FDA data

Alere INRatio®2

Primary DI
M30499007G11
Brand
Alere INRatio®2
Company
Alere San Diego, Inc.
Model
99007G1
Catalog number
99007G1
Device description
Boxed Strips, 12-PK., INRatio2 (G1)
Published
2016-10-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M30499007G11PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Prothrombin time (PT) IVD, kit, clottingA collection of reagents and other associated materials intended to be used for the quantitative measurement of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR), using a clotting method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18773088287USproductsupport@alere.com

Regulatory Flags#

DUNS number
194854949
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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