InstaTest URS-1P(100)

GUDID 00850049545921

InstaTest URS-1P is intended semi-quantitative and qualitative detection of protein in urine.

Diagnostic Automation, Inc.

Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Primary Device ID00850049545921
NIH Device Record Key10b92d80-ffff-4a42-aac5-75ec49eca416
Commercial Distribution StatusIn Commercial Distribution
Brand NameInstaTest
Version Model NumberDACDURS-1P (100)
Catalog NumberURS-1P(100)
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

Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com

Device Dimensions

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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850049545921 [Primary]

FDA Product Code

JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-22
Device Publish Date2023-06-14

Devices Manufactured by Diagnostic Automation, Inc.

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00850049545235 - AccuDiag ™2024-05-31 AccuDiag ™ H. pylori Antigen ELISA Intended to be used for the qualitative and/or quantitative detection of antigens from Heli
00850054026613 - QMedix™2024-05-31 QMedix™ EBV VCA IgG ImmunoFlourescent Assay
00850049545518 - AccuDiag™2024-05-20 AccuDiag™ Anti-Phospholipid Screen IgG/IgM ELISA
00850054026590 - QMedix™2024-05-20 QMedix™ Fecal Occult Blood RapiCard™ InstaTest
00850054026569 - QMedix™2024-05-01 QMedix™ ANA Screen ELISA
00850054026262 - AccuDiag ™2024-04-04 AccuDiag™ TSH Ultra-Sensitive ELISA

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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