Status Stick™ 5/MET Stick DOA-151-10-00

GUDID 10743816001386

Status Stick™ME/O/C/TH/P stick; 10 Test kit

PRINCETON BIOMEDITECH CORPORATION

Methamphetamine-specific IVD, kit, immunochromatographic test (ICT) assay, rapid Methamphetamine-specific IVD, kit, immunochromatographic test (ICT) assay, rapid Methamphetamine-specific IVD, kit, immunochromatographic test (ICT) assay, rapid Methamphetamine-specific IVD, kit, immunochromatographic test (ICT) assay, rapid Methamphetamine-specific IVD, kit, immunochromatographic test (ICT) assay, rapid Methamphetamine-specific IVD, kit, immunochromatographic test (ICT) assay, rapid Methamphetamine-specific IVD, kit, immunochromatographic test (ICT) assay, rapid Methamphetamine-specific IVD, kit, immunochromatographic test (ICT) assay, rapid Methamphetamine-specific IVD, kit, immunochromatographic test (ICT) assay, rapid Methamphetamine-specific IVD, kit, immunochromatographic test (ICT) assay, rapid Methamphetamine-specific IVD, kit, immunochromatographic test (ICT) assay, rapid Methamphetamine-specific IVD, kit, rapid ICT, clinical Methamphetamine-specific IVD, kit, rapid ICT, clinical Methamphetamine-specific IVD, kit, rapid ICT, clinical Methamphetamine-specific IVD, kit, rapid ICT, clinical Methamphetamine-specific IVD, kit, rapid ICT, clinical Methamphetamine-specific IVD, kit, rapid ICT, clinical Methamphetamine-specific IVD, kit, rapid ICT, clinical Methamphetamine-specific IVD, kit, rapid ICT, clinical Methamphetamine-specific IVD, kit, rapid ICT, clinical Methamphetamine-specific IVD, kit, rapid ICT, clinical Methamphetamine-specific IVD, kit, rapid ICT, clinical Methamphetamine-specific IVD, kit, rapid ICT, clinical Methamphetamine-specific IVD, kit, rapid ICT, clinical Methamphetamine-specific IVD, kit, rapid ICT, clinical Methamphetamine-specific IVD, kit, rapid ICT, clinical Methamphetamine-specific IVD, kit, rapid ICT, clinical Methamphetamine-specific IVD, kit, rapid ICT, clinical
Primary Device ID10743816001386
NIH Device Record Keyaa24b34a-b191-464e-9fa5-0d865c641ad5
Commercial Distribution StatusIn Commercial Distribution
Brand NameStatus Stick™ 5/MET Stick
Version Model NumberDOA-151-10-00
Catalog NumberDOA-151-10-00
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

Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
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
GS110743816001386 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCMEnzyme Immunoassay, Phencyclidine

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 Date2016-11-07

On-Brand Devices [Status Stick™ 5/MET Stick]

10743816001386Status Stick™ME/O/C/TH/P stick; 10 Test kit
10743816001379Status Stick™ME/O/C/TH/P stick; 35 Test kit
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.