Alere i RSV

GUDID 10811877010118

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

Alere Scarborough, Inc.

Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 10811877010118
• NIH Device Record Key: d843c766-8db5-44c6-b292-4de68522a17c
• Commercial Distribution Discontinuation: 2019-11-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Alere i RSV
• Version Model Number: 435-000
• Company DUNS: 154148498
• Company Name: Alere Scarborough, 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10811877010118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161375

FDA Product Code

• OCC: Respiratory Virus Panel Nucleic Acid Assay System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-09-12
• Device Publish Date: 2016-10-28

Devices Manufactured by Alere Scarborough, Inc.

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• 10811877010606 - Alere NMP22 BladderChek Control Kit: 2023-09-14 The Alere NMP22 BladderChek Control Kit consists of a Negative and a Positive Control solution for use as an external control fo
• 10811877010637 - Alere NMP22® Urine Collection Kit: 2023-09-14 The Alere NMP22® Urine Collection Kit is intended for the collection, stabilization, and transport of human urine which will b
• 10811877010798 - DIGIVAL Calibration Check Card Pack: 2023-09-14 A calibration check card verifies that the DIGIVAL is functioning correctly
• 00811877011477 - BinaxNOW COVID-19 Antigen Self Test: 2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 00811877011507 - BinaxNOW COVID-19 Antigen Self Test: 2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 00811877011798 - BinaxNOW COVID-19 Antigen Self Test: 2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 10811877010019 - Alere i Influenza A & B 2: 2023-09-12 A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimen