FDA.reportPublic FDA data

Fluoro-CheckTM PCT

Primary DI
00895160002427
Brand
Fluoro-CheckTM PCT
Company
NANO-DITECH CORPORATION
Model
TF3161
Catalog number
TF3161
Device description
Fluorescence In Vitro diagnostic test kit for the detection of Procalcitonin in human whole blood, serum or plasma
Published
2016-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NTMAntigen, Inflammatory Response Marker, Sepsis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTMAntigen, Inflammatory Response Marker, SepsisMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00895160002427PrimaryGS10
10895160002424Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00895160002427008951600024278951600024270895160002427
1089516000242410895160002424

GMDN Terms#

Term, Definition table
TermDefinition
Procalcitonin (PCT) IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of procalcitonin (PCT) in a clinical specimen, using a fluorescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
609-409-3300info@nanoditech.com

Regulatory Flags#

DUNS number
126544316
Device count
20
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00895160002359Nano-CheckTM NicotineAD6083AD60832016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816870023441PCT AccuLite CLIA Test System - 96 WellsMONOBIND, INC.NTM2024-09-13
00816870023458PCT AccuLite CLIA Test System - 192 WellsMONOBIND, INC.NTM2024-09-13
00816870023465PCT AccuBind ELISA Test System - 96 WellsMONOBIND, INC.NTM2024-09-13
00816870023472PCT AccuBind ELISA Test System - 192 WellsMONOBIND, INC.NTM2024-09-13
04987270234938Lumipulse G BRAHMS PCT Calibrator SetFUJIREBIO INC.NTM2018-04-02
04987270234945Lumipulse BRAHMS PCT ControlsFUJIREBIO INC.NTM2018-04-02
04987270234167Lumipulse BRAHMS PCT ControlsFUJIREBIO INC.NTM2018-04-02
04987270235058Lumipulse G BRAHMS PCT Immunoreaction CartridgesFUJIREBIO INC.NTM2018-04-02
00630414599694Atellica IM PCTSiemens Healthcare Diagnostics Inc.NTM2018-02-06
00630414599700Atellica IM PCT QCSiemens Healthcare Diagnostics Inc.NTM2018-02-06
03573026223601VIDAS® B·R·A·H·M·S PCT ™BIOMERIEUX SANTM2016-09-23
00895160002038Nano-CheckTM PCTNANO-DITECH CORPORATIONNTM2016-09-14
00895160002441Nano-CheckTM PCT plusNANO-DITECH CORPORATIONNTM2016-09-12
04260157630543B.R.A.H.M.S PCT LIAB.R.A.H.M.S GmbHNTM2016-08-17
04260157633711B.R.A.H.M.S Basiskit LIAB.R.A.H.M.S GmbHNTM2016-08-17
04260157638259B.R.A.H.M.S PCT sensitive KRYPTOR B.R.A.H.M.S GmbHNTM2016-08-17