AccessGUDID - DEVICE: Alere INRatio®2 (M30499007G11)

GUDID

Device Identifier (DI) Information

Brand Name: Alere INRatio®2
Version or Model: 99007G1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 99007G1
Company Name: ALERE SAN DIEGO, INC.

Primary DI Number: M30499007G11
Issuing Agency: HIBCC
Commercial Distribution End Date: February 01, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 194854949 *Terms of Use

Device Description: Boxed Strips, 12-PK., INRatio2 (G1)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
55983	Prothrombin time (PT) IVD, kit, clotting	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e664ffd7-a072-4bef-b983-2618b6358f3e
Public Version Date: August 23, 2023
Public Version Number: 3
DI Record Publish Date: October 26, 2016