DELFIA hFSH kit A017-201

GUDID 06438147009183

Time-resolved fluoroimmunoassay for the quantitative determination of human follicle stimulating hormone (hFSH).

Wallac Oy

Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID06438147009183
NIH Device Record Key69fa7539-62bd-4fac-ade1-03689a1704a4
Commercial Distribution Discontinuation2016-11-04
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDELFIA hFSH kit
Version Model NumberA017-201
Catalog NumberA017-201
Company DUNS540156544
Company NameWallac Oy
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106438147009183 [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 Number2
Public Version Date2018-03-29
Device Publish Date2016-02-11

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