US Urine Examiner Kit

GUDID 10850054552058

US Urine Examiner Kit

Quest Diagnostics

Specimen container mailer, insulated
Primary Device ID10850054552058
NIH Device Record Key5e8ee0d5-c747-45cc-81e5-3b713e571e8e
Commercial Distribution StatusIn Commercial Distribution
Brand NameUS Urine Examiner Kit
Version Model NumberExempt
Company DUNS189222334
Company NameQuest Diagnostics
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone913-577-1784
Emaillisa.x.christo@questdiagnostics.com
Phone913-577-1784
Emaillisa.x.christo@questdiagnostics.com
Phone913-577-1784
Emaillisa.x.christo@questdiagnostics.com
Phone913-577-1784
Emaillisa.x.christo@questdiagnostics.com
Phone913-577-1784
Emaillisa.x.christo@questdiagnostics.com
Phone913-577-1784
Emaillisa.x.christo@questdiagnostics.com
Phone913-577-1784
Emaillisa.x.christo@questdiagnostics.com
Phone913-577-1784
Emaillisa.x.christo@questdiagnostics.com
Phone913-577-1784
Emaillisa.x.christo@questdiagnostics.com
Phone913-577-1784
Emaillisa.x.christo@questdiagnostics.com
Phone913-577-1784
Emaillisa.x.christo@questdiagnostics.com
Phone913-577-1784
Emaillisa.x.christo@questdiagnostics.com
Phone913-577-1784
Emaillisa.x.christo@questdiagnostics.com
Phone913-577-1784
Emaillisa.x.christo@questdiagnostics.com
Phone913-577-1784
Emaillisa.x.christo@questdiagnostics.com
Phone913-577-1784
Emaillisa.x.christo@questdiagnostics.com
Phone913-577-1784
Emaillisa.x.christo@questdiagnostics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850054552051 [Primary]
GS110850054552058 [Package]
Contains: 00850054552051
Package: [10 Units]
In Commercial Distribution
GS120850054552055 [Package]
Contains: 00850054552051
Package: [25 Units]
In Commercial Distribution
GS130850054552052 [Package]
Contains: 00850054552051
Package: [50 Units]
In Commercial Distribution
GS140850054552059 [Package]
Contains: 00850054552051
Package: [100 Units]
In Commercial Distribution

FDA Product Code

OIEUrine Collection Kit (Excludes Hiv Testing)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-09
Device Publish Date2024-05-01

Devices Manufactured by Quest Diagnostics

00850054552068 - K-QUE-ACT-001 REV0022026-03-05 QCard Blood Collection Kit (WHS)
00850054552075 - K-QUE-ACT-003 REV0022026-03-05 QCard Collection Kit (WHS)
00850054552082 - K-QUE-ACT-004 REV0022026-03-05 QCard Collection Kit
00850054552099 - K-QUE-ACT-005 REV0022026-03-05 QCard Collection Kit (WHS)
00850054552105 - K-QUE-ACT-006 REV0012026-03-05 QCard Collection Kit (WHS)
00850054552112 - K-QUE-ACT-007 REV0002026-03-05 QCard Collection Kit (WHS)
00850054552129 - K-QUE-KED-001 REV0002026-03-05 QCard Collection Kit
10850054552034 - US Blood And Urine Kit2024-05-09 US Blood And Urine Kit
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.