FDA.reportPublic FDA data

Accutest iFOBT - Dual Sample Specimen Collection Kits

Primary DI
10763924632500
Brand
Accutest iFOBT - Dual Sample Specimen Collection Kits
Company
JANT PHARMACAL CORPORATION
Model
CS632
Device description
Accutest iFOBT - Dual Sample Specimen Collection KitsContains: 25 patient specimen collection kits
Published
2016-09-23
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
KHEReagent, Occult Blood

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHEReagent, Occult BloodHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063693000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063693000FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TESTNew Bay Bioresearch Co. , Ltd.2007-05-11KHE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10763924632500PrimaryGS10
00763924632503Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076392463250010763924632500
00763924632503007639246325037639246325030763924632503

GMDN Terms#

Term, Definition table
TermDefinition
Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin and/or transferrin) within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
797393659
Device count
25
Kit
true
Lot or batch
true
Expiration date on label
true

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