FDA.reportPublic FDA data

Nano-CheckerTM 710 Reader

Primary DI
00895160002014
Brand
Nano-CheckerTM 710 Reader
Company
NANO-DITECH CORPORATION
Model
710V
Catalog number
NDT710
Device description
Analyzer for Nano-CheckTM line of diagnostic products.
Published
2019-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JQTDensitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQTDensitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) ClinicaClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00895160002014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00895160002014008951600020148951600020140895160002014

GMDN Terms#

Term, Definition table
TermDefinition
Photometric immunoassay analyser IVDA portable, electrically-powered instrument, intended to be used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card) after exposure to a clinical specimen, to provide a quantitative, semi-quantitative and/or qualitative in vitro determination of chemical substances and/or biological markers in a clinical specimen. The instrument uses photometry to detect visual markers that result from the immunological reaction between the reagents and the specimen. It is intended to be used by health professionals for rapid in vitro diagnostic measurements at the point-of-care or in the laboratory.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-609-406-3300info@nanoditech.com

Regulatory Flags#

DUNS number
126544316
Device count
1
Premarket exempt
true
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00895160002427Fluoro-CheckTM PCTTF3161TF31612016-10-05
00895160002878Nano-Check™ Influenza A+B TestMD81532026-01-22
10895160002875Nano-Check™ Influenza A+B TestMD81532026-01-22
00895160002960Nano-Check Influenza+COVID-19 Dual TestMD81542026-01-16
10895160002967Nano-Check Influenza+COVID-19 Dual TestMD81542026-01-16
00895160002847Nano-Check Influenza+COVID-19 Dual TestMD8151E2024-08-08
10895160002844Nano-Check Influenza+COVID-19 Dual TestMD8151E2024-08-08
00895160002854Nano-Check RSV TestMD81522024-08-08
00895160002861Nano-Check TM COVID-19 Antigen TestMD-8147MD-8147 2T2024-04-01
10895160002868Nano-Check TM COVID-19 Antigen TestMD-8147MD-8147 2T2024-04-01
00895160002786Nano-Check TM COVID-19 Antigen TestMD-8147MD-8147-20T2020-11-18
00895160002243Nano-Check™ OPI TestAD41832023-06-27
10895160002240Nano-Check™ OPI TestAD41832023-06-27
00895160002663Nano-CheckTM COVID-19 IgG/IgM Antibody TestMD81452020-04-10
00895160002670Fluoro-CheckTM CRP Test TF31632020-09-22
00895160002687Nano-Check TM Strep A TestMD81482022-03-15
00895160002694Nano-Check TM CRP plus TestCD71572022-03-15
00895160002724Nano-Check TM COVID-19 IgG Antibody TestMD81462020-09-22
00895160002793Fluoro-Check TM COVID-19 Antigen TestTF-81502020-11-25
00895160002120Nano-CheckTM AMI 2 in 1CD202PCD202P2016-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07070060008042Alere Afinion™ AS100Abbott Diagnostics Technologies ASJQT2023-10-26
07070060014616Afinion™ 2Abbott Diagnostics Technologies ASJQT2023-10-26
07070060014623Afinion™ 2Abbott Diagnostics Technologies ASJQT2023-10-26
07070060014692Afinion™ 2Abbott Diagnostics Technologies ASJQT2023-10-26
07070060014708Afinion™ 2Abbott Diagnostics Technologies ASJQT2023-10-26
EVIRUVCCAM1ViraChip ReaderViramed Biotech AGJQT2023-07-17
EVIRUVCSCA1ViraChip ScannerViramed Biotech AGJQT2023-07-17
04049016068785EUROLineScanEUROIMMUN Medizinische Labordiagnostika AGJQT2022-12-08
00867802000290xReader SystemESCREEN, INC.JQT2016-09-16
00816057020041ASiManager-ATARLINGTON SCIENTIFIC, INC.JQT2016-07-08