Nano-CheckTM DAT 6M AD603U

GUDID 00895160002632

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

NANO-DITECH CORPORATION

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00895160002632
NIH Device Record Key1ec6bead-2bd9-4e2b-9668-5607387e4753
Commercial Distribution StatusIn Commercial Distribution
Brand NameNano-CheckTM DAT 6M
Version Model NumberAD603U
Catalog NumberAD603U
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
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100895160002632 [Primary]
GS110895160002639 [Unit of Use]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-11
Device Publish Date2019-07-03

On-Brand Devices [Nano-CheckTM DAT 6M]

00895160002632In Vitro Diagnostic Test kit for the detection of Tricyclic antidepressant, Opiate, Methamphetam
00895160002625In Vitro Diagnostic Test kit for the detection of Tricyclic antidepressant, Opiate, Benzoylecgon
00895160002229In Vitro Diagnostic Test kit for the Detection of Cannabinoids, Opiate, Benzoylecgonine, Barbitu

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.