ID NOW RSV Control Swab Kit

GUDID 10811877010538

Control Swabs intended for use only with the ID NOW RSV product.

Alere Scarborough, Inc.

Respiratory syncytial virus (RSV) nucleic acid IVD, control
Primary Device ID10811877010538
NIH Device Record Key3e63784a-c16a-48a1-93b0-a3c4da13fc8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameID NOW RSV Control Swab Kit
Version Model Number435-080
Company DUNS154148498
Company NameAlere Scarborough, 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110811877010538 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OCCRespiratory Virus Panel Nucleic Acid Assay System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-12
Device Publish Date2018-10-29

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