AccuSign® DOA 8 card DOA-280-25-04

GUDID 10743816000457

AccuSign® DOA 8 T/O/C/A//BZ/BA/TC/P card; 25 Test kit; CE

PRINCETON BIOMEDITECH CORPORATION

Phencyclidine (PCP) IVD, kit, immunochromatographic test (ICT)
Primary Device ID10743816000457
NIH Device Record Key41ea296c-c11e-4960-9f9d-08371863764e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccuSign® DOA 8 card
Version Model NumberDOA-280-25-04
Catalog NumberDOA-280-25-04
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

Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.com
Phone7322741000
Emailinfo@pbmc.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
GS110743816000457 [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 Date2016-09-23

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10743816001645 - Status™ COVID-19 Antigen Rapid Test for Home Use2023-10-30 Status™ COVID-19 Antigen for Home Use, 25 Test Kit
10743816000532 - BioSign® hCG card2023-07-06 BioSign® hCG card; 35 Test kit
10743816000556 - Status hCG card2023-07-06 Status hCG card; 35 Test kit
10743816000563 - Status hCG card2023-07-06 Status hCG card; 12 Test sample kit
10743816000570 - BioSign® hCG card2023-07-06 BioSign® hCG card; 35 Test kit; CE
10743816000587 - BioSign® hCG card2023-07-06 BioSign® hCG card; 10 Test kit; CE

Trademark Results [AccuSign]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACCUSIGN
ACCUSIGN
74639698 1997637 Live/Registered
Princeton BioMeditech Corporation
1995-03-01
ACCUSIGN
ACCUSIGN
73691298 1497239 Live/Registered
PHILLIPS, ROD
1987-10-23

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