FDA.reportPublic FDA data

URINE COLLECTION KIT

Primary DI
M769MAUTEST391
Brand
URINE COLLECTION KIT
Company
Home Access Health Corporation
Model
39
Device description
URINE(MAU) COLLECTION KIT PCP-No Internet
Published
2020-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M769MAUTEST391PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
848511283
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
M769HIVSTANDARD211HIV-1 Standard Test System212015-09-03
M769A1C821HOME ACCESS A1C TEST822016-09-09
M769A1CPCP841HOME ACCESS A1C TEST842017-10-06
M769CHOLESTEROL801CHECK UP AMERICA CHOLESTEROL PANEL802016-09-09
M769CHOLESTEROL811CHECK UP AMERICAL CHOLESTEROL PANEL812016-09-09
M769HCV271Hepatitis C Check272015-09-03
M769HIVEXPRESS201Express HIV-1 Test System202015-09-03
M769FITCHEK351FIT-CHEK352016-09-09
M769FITCHEK361FIT-CHEK362017-11-02
M769FITCHEK331FIT-CHEK332019-06-22
M769FITCHEK341FIT-CHEK342018-06-26
M769MAUTEST371URINE COLLECTION KIT372020-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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