FDA.report

OSOM iFOBT Stool Collection Tube

Primary DI
00742860100321
Brand
OSOM iFOBT Stool Collection Tube
Company
SEKISUI DIAGNOSTICS, LLC
Model
1001
Catalog number
1001
Published
2018-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KHEREAGENT, OCCULT BLOOD

Product Code Classifications

CodeDeviceSpecialtyClass
KHEReagent, Occult BloodHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00742860100321PrimaryGS10
10742860100328Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00742860100321007428601003217428601003210742860100321
1074286010032810742860100328

GMDN Terms

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) 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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Do Not Freeze
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
966812344
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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