FDA.reportPublic FDA data

InSure FIT

Primary DI
00850093003033
Brand
InSure FIT
Company
ENTERIX INC.
Model
01
Catalog number
16800
Device description
InSure FIT FOBT Controls - Contains 1 Positive Control and 1 Negative Control (1.5mL each)
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OSLControl, Fecal Occult Blood

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSLControl, Fecal Occult BloodHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101831000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101831000ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800Bionostics, Inc.2010-10-01OSL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850093003033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850093003033008500930030338500930030330850093003033

GMDN Terms#

Term, Definition table
TermDefinition
Faecal occult blood IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from heat and direct sun light
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit46 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002224009
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850093003019InSure FIT01800252016-09-20
00850093003040InSure FIT012016-09-20
00850093003187InSure FIT01900022016-10-03
00850093003231InSure® ONE™0180025.012018-01-05
00850093003279InSure® ONE™0190030.012018-01-05
00850093003309InSure® ONE™0190002.012018-01-05
00850093003354InSure® ONE™0190035.012018-01-05
00850093003316InSure® ONE™012018-01-05
00850093003064InSure FIT01150222016-09-14
00850093003071InSure FIT01110182016-10-03
00850093003286InSure® ONE™0111018.012018-01-05
00850093003088InSure FIT012016-09-20
00850093003323InSure® ONE™012018-01-05
10850093003085InSure FIT012016-09-20
00850093003095InSure FIT01141032016-09-20
00850093003293InSure® ONE™0114103.012018-01-05
30850093003317InSure® ONE™012018-01-05
00850093003347InSure® ONE™012018-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00742860100185OSOM iFOB Control KitSEKISUI DIAGNOSTICS, LLCOSL2017-01-10