Status DS™ TCA card DOA-209-35-01

GUDID 10743816001539

Status DS™® TCA card; 35 Test kit

PRINCETON BIOMEDITECH CORPORATION

Tricyclic antidepressant IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID10743816001539
NIH Device Record Key874d73b9-54bc-41ce-afe9-8cbd2e67f225
Commercial Distribution StatusIn Commercial Distribution
Brand NameStatus DS™ TCA card
Version Model NumberDOA-209-35-01
Catalog NumberDOA-209-35-01
Company DUNS362917692
Company NamePRINCETON BIOMEDITECH CORPORATION
Device Count1
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8005262125
Emailinfo@lifesignmed.com
Phone8005262125
Emailinfo@lifesignmed.com
Phone8005262125
Emailinfo@lifesignmed.com
Phone8005262125
Emailinfo@lifesignmed.com
Phone8005262125
Emailinfo@lifesignmed.com
Phone8005262125
Emailinfo@lifesignmed.com
Phone8005262125
Emailinfo@lifesignmed.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

Device Identifiers

Device Issuing AgencyDevice ID
GS110743816001539 [Primary]

FDA Product Code

MLKThin Layer Chromatography, Tricyclic Antidepressant Drugs

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-16
Device Publish Date2020-01-08

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