AccessGUDID - DEVICE: Alere i RSV (10811877010118)

GUDID

Device Identifier (DI) Information

Brand Name: Alere i RSV
Version or Model: 435-000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Alere Scarborough, Inc.

Primary DI Number: 10811877010118
Issuing Agency: GS1
Commercial Distribution End Date: November 15, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 154148498 *Terms of Use

Device Description: A rapid, automated, molecular test for the qualitative detection of respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal specimens.

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?
49506	Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from respiratory syncytial virus (RSV) in a clinical specimen, using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OCC	Respiratory Virus Panel Nucleic Acid Assay System
OEM	Human Metapneumovirus (Hmpv) Rna Assay System
OOI	Real Time Nucleic Acid Amplification System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161375	000

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: d843c766-8db5-44c6-b292-4de68522a17c
Public Version Date: September 12, 2023
Public Version Number: 3
DI Record Publish Date: October 28, 2016