Nano-CheckTM AMI 2 in 1 CD202P

GUDID 00895160002120

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

NANO-DITECH CORPORATION

Multiple cardiac marker IVD, reagent
Primary Device ID00895160002120
NIH Device Record Keybc25f1a5-c9a1-4da3-937e-00f60f70695e
Commercial Distribution Discontinuation2022-12-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameNano-CheckTM AMI 2 in 1
Version Model NumberCD202P
Catalog NumberCD202P
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100895160002120 [Primary]
GS110895160002127 [Unit of Use]

FDA Product Code

DDRMyoglobin, Antigen, Antiserum, Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-06-29
Device Publish Date2016-09-14

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