AutoDELFIA hAFP kit B079-212

GUDID 06438147321322

Time-resolved fluoroimmunoassay for the quantitative determination of human alphafetoprotein (hAFP)

Wallac Oy

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay
Primary Device ID06438147321322
NIH Device Record Key20a694f7-f6b6-4f8b-88b8-abe76859a464
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutoDELFIA hAFP kit
Version Model NumberB079-212
Catalog NumberB079-212
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
GS106438147321322 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LOKKit, Test, Alpha-Fetoprotein For Neural Tube Defects

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-21
Device Publish Date2014-09-24

On-Brand Devices [AutoDELFIA hAFP kit]

06438147321322Time-resolved fluoroimmunoassay for the quantitative determination of human alphafetoprotein (hA
06438147321315Time-resolved fluoroimmunoassay for the quantitative determination of human alpha-fetoprotein (h

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