Nano-Check RSV Test

GUDID 00895160002854

The Nano-Check RSV Test is a rapid immunochromatographic assay for the qualitative detection of respiratory syncytial virus (RSV) nucleoprotein antigen in anterior nasal swab specimens from patients with signs and symptoms of respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in infants and pediatric patients aged 6 months to 6 years old, and adults over 60 years of age.

NANO-DITECH CORPORATION

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical
Primary Device ID00895160002854
NIH Device Record Key2e6d5789-079c-47db-a16e-6a4fe9e2cce3
Commercial Distribution StatusIn Commercial Distribution
Brand NameNano-Check RSV Test
Version Model NumberMD8152
Company DUNS126544316
Company NameNANO-DITECH CORPORATION
Device Count20
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com
Phone609-409-3300
Emailinfo@nanoditech.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100895160002854 [Primary]
GS110895160002851 [Unit of Use]

FDA Product Code

GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-16
Device Publish Date2024-08-08

Devices Manufactured by NANO-DITECH CORPORATION

10895160002844 - Nano-Check Influenza+COVID-19 Dual Test2024-08-16 The Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simult
00895160002854 - Nano-Check RSV Test2024-08-16The Nano-Check RSV Test is a rapid immunochromatographic assay for the qualitative detection of respiratory syncytial virus (RSV) nucleoprotein antigen in anterior nasal swab specimens from patients with signs and symptoms of respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in infants and pediatric patients aged 6 months to 6 years old, and adults over 60 years of age.
00895160002854 - Nano-Check RSV Test2024-08-16 The Nano-Check RSV Test is a rapid immunochromatographic assay for the qualitative detection of respiratory syncytial virus (RSV
10895160002868 - Nano-Check TM COVID-19 Antigen Test2024-04-09 An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2.
10895160002240 - Nano-Check™ OPI Test2023-07-05 A rapid, self-controlled, immunoassay for the qualitative detection of Heroin, Codeine, Morphine and Hydrocodone called opiates,
00895160002120 - Nano-CheckTM AMI 2 in 12023-06-29 In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I and Myoglobin in human whole blood, serum and plasma
00895160002359 - Nano-CheckTM Nicotine2023-06-29 In Vitro Diagnostic Test kit for the detection of Cotinine in human urine
00895160002366 - Nano-CheckTM Nicotine 5002023-06-29 In Vitro Diagnostic Test kit for the detection of Cotinine in human urine
00895160002410 - Fluoro-CheckTM cTnI2023-06-29 Fluorescence in vitro diagnostic test kit for the detection of cardiac troponin I in human while blood, serum and plasma of myoc
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