Fluoro-CheckTM CRP Test

GUDID 10895160002677

A in vitro diagnostic test for the quantitative determination of C-reactive protein as an aid in the detection and evaluation of infection, tissue injury, inflammation, and associated diseases.

NANO-DITECH CORPORATION

C-reactive protein (CRP) IVD, kit, fluorescent immunoassay
Primary Device ID10895160002677
NIH Device Record Keyaeb4f9b0-35a7-4d26-a5c3-4fa01f75d157
Commercial Distribution StatusIn Commercial Distribution
Brand NameFluoro-CheckTM CRP Test
Version Model NumberTF3163
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-609-406-3300
Emailinfo@nanoditech.com
Phone1-609-406-3300
Emailinfo@nanoditech.com
Phone1-609-406-3300
Emailinfo@nanoditech.com
Phone1-609-406-3300
Emailinfo@nanoditech.com
Phone1-609-406-3300
Emailinfo@nanoditech.com
Phone1-609-406-3300
Emailinfo@nanoditech.com
Phone1-609-406-3300
Emailinfo@nanoditech.com
Phone1-609-406-3300
Emailinfo@nanoditech.com
Phone1-609-406-3300
Emailinfo@nanoditech.com
Phone1-609-406-3300
Emailinfo@nanoditech.com
Phone1-609-406-3300
Emailinfo@nanoditech.com
Phone1-609-406-3300
Emailinfo@nanoditech.com
Phone1-609-406-3300
Emailinfo@nanoditech.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100895160002670 [Primary]
GS110895160002677 [Unit of Use]

FDA Product Code

DCNSystem, Test, C-Reactive Protein

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-30
Device Publish Date2020-09-22

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