FDA.reportPublic FDA data

US Urine Examiner Kit

Primary DI
10850054552058
Brand
US Urine Examiner Kit
Company
Quest Diagnostics
Model
Exempt
Device description
US Urine Examiner Kit
Published
2024-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OIEUrine Collection Kit (Excludes Hiv Testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIEUrine Collection Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850054552058PackageGS110In Commercial Distribution
20850054552055PackageGS125In Commercial Distribution
30850054552052PackageGS150In Commercial Distribution
40850054552059PackageGS1100In Commercial Distribution
00850054552051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085005455205810850054552058
2085005455205520850054552055
3085005455205230850054552052
4085005455205940850054552059
00850054552051008500545520518500545520510850054552051

GMDN Terms#

Term, Definition table
TermDefinition
Specimen container mailer, insulatedA non-sterile tube, box, or envelope designed to transport a specimen container/receptacle by mail and to provide protection and insulation for the container and its specimen content. It can be used for mail services internal or external to healthcare facilities. It includes insulation intended to provide a thermal barrier between the specimen and the environment to preserve temperature-sensitive samples. The device is also intended to protect the specimen container (e.g., glass vial, bottle, tube, or slide) from adverse conditions that could cause breakage. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
913-577-1784lisa.x.christo@questdiagnostics.com

Regulatory Flags#

DUNS number
189222334
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850054552136K-QUE-ACT-001-PRK-QUE-ACT-001-PR2026-05-01
00850054552068K-QUE-ACT-001 REV002K-QUE-ACT-001 REV0022026-02-25
00850054552075K-QUE-ACT-003 REV002K-QUE-ACT-003 REV0022026-02-25
00850054552082K-QUE-ACT-004 REV002K-QUE-ACT-004 REV0022026-02-25
00850054552099K-QUE-ACT-005 REV002K-QUE-ACT-005 REV0022026-02-25
00850054552105K-QUE-ACT-006 REV001K-QUE-ACT-006 REV0012026-02-25
00850054552112K-QUE-ACT-007 REV000K-QUE-ACT-007 REV0002026-02-25
00850054552129K-QUE-KED-001 REV000K-QUE-KED-001 REV0002026-02-25
00850054552037US Blood And Urine KitExempt2024-05-01
00810121520000Blood Specimen Collection Kit (EPH)Exempt2023-08-23
00868586000247HairCheck-DT (THC)K0402572016-09-23
10869419000219Express ResultsTMUDOA-10CA-0503-01 2016-09-24
00850054552044US Paramed Collection Oral Fluid KitExempt2024-05-01
00850054552051US Urine Examiner KitExempt2024-05-01
10850054552034US Blood And Urine KitExempt2024-05-01
10850054552041US Paramed Collection Oral Fluid KitExempt2024-05-01
00868586000292Quest Diagnostics Oral Fluid Oxycodone HEIAPVH-Exempt2017-10-02
00850054552013US Agent Collection Oral Fluid KitExempt2024-01-15
10869419000202Express ResultsTM UDOA-6CA-0503-012016-09-24
10869419000233Express ResultsTMUDOA-12CE-0712-012016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160518397MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OIE2026-04-07
50382903649346BD Vacutainer Urine Complete Cup KitBECTON, DICKINSON AND COMPANYOIE2026-02-03
00382903649341BD Vacutainer Urine Complete Cup KitBECTON, DICKINSON AND COMPANYOIE2026-02-03
19120126131407VACUETTEGreiner Bio-One GmbHOIE2026-01-26
19120126131414VACUETTEGreiner Bio-One GmbHOIE2026-01-26
19120126131421VACUETTEGreiner Bio-One GmbHOIE2026-01-26
19120126131469VACUETTEGreiner Bio-One GmbHOIE2026-01-26
29120126131404VACUETTEGreiner Bio-One GmbHOIE2026-01-26
29120126131411VACUETTEGreiner Bio-One GmbHOIE2026-01-26
29120126131428VACUETTEGreiner Bio-One GmbHOIE2026-01-26
29120126131466VACUETTEGreiner Bio-One GmbHOIE2026-01-26
50382903649322BD Vacutainer Urine Complete Cup KitBECTON, DICKINSON AND COMPANYOIE2026-01-05
00382903649327BD Vacutainer Urine Complete Cup KitBECTON, DICKINSON AND COMPANYOIE2026-01-05
00810185250547TherapakTherapak LLCOIE2025-08-11
00810185250554TherapakTherapak LLCOIE2025-08-11
00850024881846LetsGetChecked Urine Sample Collection Kit (UACR/UACRL)PRIVAPATH DIAGNOSTICS LIMITEDOIE2025-07-07
00840117338029LabChoice Midstream Specimen Catch Kit, SterileDynarex CorporationOIE2025-03-14
00860013362904RTL Urine Collection KitRealtime Laboratories, Inc.OIE2025-02-28
G7327021Everlywell Blood and Urine Collection KitEverly Health, Inc.OIE2025-02-18
G7324001Everlywell Urine Collection KitEverly Health, Inc.OIE2025-02-14
G7324011Everlywell Urine Collection KitEverly Health, Inc.OIE2025-02-14
10860009616032Kidney Stone Transportation KitDitek Consulting, LLCOIE2024-11-19
05055273220018PlaySafe™ RANDOX LABORATORIES LIMITEDOIE2024-10-01
00850054552051US Urine Examiner KitQuest DiagnosticsOIE2024-05-01
04580455980851Urine Raku-Ryu CupTAKAHASHI KEISEI CORPORATIONOIE2024-03-01
04580455981025Urine Raku-Ryu CupTAKAHASHI KEISEI CORPORATIONOIE2024-03-01
00810113420028INDICAID health Sexual Health 2Phase Diagnostics, Inc.OIE2023-10-03
00860010959206US Biotek LaboratoriesU.S. Biotek Laboratories LLCOIE2023-09-15
00810040820625Cue Sample Collection Kit Cue Health Inc.OIE2023-02-27
00860193001761UroMap Specimen Collection KitCAREDX, INC.OIE2023-02-10