Nano-CheckTM DAT 4M AD405U

GUDID 00895160002540

In Vitro Diagnostic Test kit for the detection of Tricyclic antidepressant, Amphetamine, Methamphetamine, and Opiate in human urine.

NANO-DITECH CORPORATION

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Primary Device ID00895160002540
NIH Device Record Key3726eb36-fa23-4dea-9406-71d7c908ffc5
Commercial Distribution StatusIn Commercial Distribution
Brand NameNano-CheckTM DAT 4M
Version Model NumberAD405U
Catalog NumberAD405U
Company DUNS126544316
Company NameNANO-DITECH CORPORATION
Device Count25
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

Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
Emailinfo@nanoditech.com
Phone1-609-409-3300
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
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
GS100895160002540 [Primary]
GS110895160002547 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-05-24
Device Publish Date2018-12-17

On-Brand Devices [Nano-CheckTM DAT 4M]

00895160002564In Vitro Diagnostic Test kit for the detection of Tricyclic antidepressant, Amphetamine, Methamp
00895160002540In Vitro Diagnostic Test kit for the detection of Tricyclic antidepressant, Amphetamine, Methamp
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