US Biotek Laboratories

Primary DI
00860010959220
Brand
US Biotek Laboratories
Company
U.S. Biotek Laboratories LLC
Model
1.0
Catalog number
UTK001
Device description
Single-use convenient urine transport kit includes transport tube(s), and return packing for mailing to testing laboratory.
Published
2023-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
OHZUrine Transport Kit (Excludes Hiv Testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHZUrine Transport Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010959220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010959220008600109592208600109592200860010959220

GMDN Terms#

Term, Definition table
TermDefinition
Urine specimen collection kit IVDA collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
094709776
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010959206US Biotek Laboratories1.0DUK0012023-09-15
00860010959244US Biotek Laboratories1.0DBK0012023-09-15
00860010959268US Biotek Laboratories1.0SCK0012023-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009877917RenalytixAI Urine Collection KitRenalytix Ai, Inc.OHZ2022-05-06
00196852375677RenalytixAI Urine Collection KitRenalytix Ai, Inc.OHZ2022-05-06
G229RENX30110031RenalytixAI Urine Collection KitRenalytix Ai, Inc.OHZ2022-05-06