INSTANT-VIEW FOB Test - complete kit, 25 test

GUDID 20796918001904

INSTANT-VIEW FOB Test Fecal Occult Blood – Cassette with mailer 25 tests

ALFA SCIENTIFIC DESIGNS, INC.

Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid Faecal occult blood IVD, kit, rapid ICT, clinical Faecal occult blood IVD, kit, rapid ICT, clinical Faecal occult blood IVD, kit, rapid ICT, clinical Faecal occult blood IVD, kit, rapid ICT, clinical Faecal occult blood IVD, kit, rapid ICT, clinical Faecal occult blood IVD, kit, rapid ICT, clinical
Primary Device ID20796918001904
NIH Device Record Keyaa850799-6494-4c2a-aacf-8f18d798668c
Commercial Distribution StatusIn Commercial Distribution
Brand NameINSTANT-VIEW FOB Test - complete kit, 25 test
Version Model Number05-7601-25
Company DUNS176391167
Company NameALFA SCIENTIFIC DESIGNS, INC.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100796918001900 [Unit of Use]
GS120796918001904 [Primary]

FDA Product Code

KHEReagent, Occult Blood

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-04-06
Device Publish Date2019-07-01

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