InstaTest™ 121151-1-44

GUDID 00850054026323

Fentanyl RapiCard InstaTest

Diagnostic Automation, Inc.

Fentanyl IVD, kit, rapid ICT, clinical
Primary Device ID00850054026323
NIH Device Record Keya85654b9-9a4f-4982-af79-33e6418c9985
Commercial Distribution StatusIn Commercial Distribution
Brand NameInstaTest™
Version Model NumberDACD121151-1-44
Catalog Number121151-1-44
Company DUNS878252071
Company NameDiagnostic Automation, Inc.
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

Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850054026323 [Primary]

FDA Product Code

DJGEnzyme Immunoassay, Opiates

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-16
Device Publish Date2023-10-06

On-Brand Devices [InstaTest™]

00894175000619ASO Latex Test Kit: Diagnostic Automation Inc. Latex agglutination slide test for the Qualitativ
00850054026323Fentanyl RapiCard InstaTest

Trademark Results [InstaTest]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INSTATEST
INSTATEST
79147000 not registered Dead/Abandoned
LBC TECHNOLOGIES LIMITED
2014-03-13
INSTATEST
INSTATEST
79128287 not registered Dead/Abandoned
LBC TECHNOLOGIES LIMITED
2012-10-31
INSTATEST
INSTATEST
79124706 not registered Dead/Abandoned
LBC TECHNOLOGIES LIMITED
2012-07-03
INSTATEST
INSTATEST
78076520 not registered Dead/Abandoned
Advanced Medical Systems, Inc.
2001-07-30
INSTATEST
INSTATEST
76200988 2698435 Live/Registered
DIAGNOSTIC AUTOMATION, INC.
2001-01-29
INSTATEST
INSTATEST
74461474 2039594 Dead/Cancelled
L. B. Couplings (Camden) Limited
1993-11-12
INSTATEST
INSTATEST
73186408 1127364 Dead/Cancelled
CARTER-WALLACE, INC.
1978-09-21

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