FIT-CHEK

Primary DI
M769FITCHEK331
Brand
FIT-CHEK
Company
Home Access Health Corporation
Model
33
Device description
Fecal Immunochemical Test to screen for Colorectal cancer.
Published
2019-06-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M769FITCHEK331PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Home faecal specimen collection kitA collection of non-sterile devices and materials intended to be used by a layperson to collect and mail a faecal (stool) sample to a clinical laboratory for diagnostic testing or screening purposes (e.g., occult blood, cytology). The kit includes a specimen container(s), preservative, and other items [e.g., collection assistive device(s), labels, and a container with a requisition form for mailing to the laboratory]. This is a single-use device.

Sterilization Methods#

Method table
Method

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
M769FITCHEK341FIT-CHEK342018-06-26
M769MAUTEST371URINE COLLECTION KIT372020-09-18
M769MAUTEST391URINE COLLECTION KIT392020-09-19