Status DS™ 8 card DOA-280-25-01

GUDID 10743816000433

Status DS™ T/O/C/A//BZ/BA/TC/P card; 25 Test kit

PRINCETON BIOMEDITECH CORPORATION

Phencyclidine (PCP) IVD, kit, immunochromatographic test (ICT)
Primary Device ID10743816000433
NIH Device Record Key603afaa9-7833-471a-bc83-513cc094417d
Commercial Distribution StatusIn Commercial Distribution
Brand NameStatus DS™ 8 card
Version Model NumberDOA-280-25-01
Catalog NumberDOA-280-25-01
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
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
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
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
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
GS110743816000433 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JXMEnzyme Immunoassay, Benzodiazepine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-05-24
Device Publish Date2016-09-23

On-Brand Devices [Status DS™ 8 card]

10743816000440Status DS™ T/O/C/A//BZ/BA/TC/P card; 10 Test kit
10743816000433Status DS™ T/O/C/A//BZ/BA/TC/P card; 25 Test kit

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