Nano-CheckTM AMI cTnI CD7140

GUDID 00895160002113

In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I in human whole blood, plasma and serum

NANO-DITECH CORPORATION

Troponin I IVD, kit, rapid ICT, clinical
Primary Device ID00895160002113
NIH Device Record Keyaac80446-ca04-4292-b1dc-4eca9c83774f
Commercial Distribution StatusIn Commercial Distribution
Brand NameNano-CheckTM AMI cTnI
Version Model NumberCD7140
Catalog NumberCD7140
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

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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100895160002110 [Unit of Use]
GS100895160002113 [Primary]

FDA Product Code

MMIImmunoassay Method, Troponin Subunit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-06-10
Device Publish Date2016-09-14

On-Brand Devices [Nano-CheckTM AMI cTnI]

00895160002113In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I in human whole blood, plasm
00895160002076In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I in human serum and plasma
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