INSTANT-VIEW Morphine (2000) Urine Dip Cassette Test

GUDID 10796918000504

INSTANT-VIEW Morphine (2000) Urine Dip Cassette Test

ALFA SCIENTIFIC DESIGNS, INC.

Opiate/opiate metabolite IVD, kit, immunochromatographic test (ICT)
Primary Device ID10796918000504
NIH Device Record Key90005510-8747-4ca0-9ead-a2ac9dcfd4e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameINSTANT-VIEW Morphine (2000) Urine Dip Cassette Test
Version Model Number03-3092QW
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 Datefalse
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
GS100796918000507 [Unit of Use]
GS110796918000504 [Primary]

FDA Product Code

DOERadioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-05-01
Device Publish Date2016-09-22

Devices Manufactured by ALFA SCIENTIFIC DESIGNS, INC.

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30796918001901 - INSTANT-VIEW FOB Test - complete kit, 50 test2020-04-06 INSTANT-VIEW FOB Test Fecal Occult Blood – Cassette with mailer 50 tests

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