INSTANT-VIEW FSH Cassette Test

GUDID 10796918000139

INSTANT-VIEW FSH Cassette Test

ALFA SCIENTIFIC DESIGNS, INC.

Follicle stimulating hormone (FSH) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID10796918000139
NIH Device Record Key70ae6247-0b8d-4c73-975c-79b99792b44a
Commercial Distribution StatusIn Commercial Distribution
Brand NameINSTANT-VIEW FSH Cassette Test
Version Model Number02-2562
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
GS100796918000132 [Unit of Use]
GS110796918000139 [Primary]

FDA Product Code

CGJRadioimmunoassay, Follicle-Stimulating Hormone

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 Date2016-09-21

Devices Manufactured by ALFA SCIENTIFIC DESIGNS, INC.

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