AutoDELFIA Inhibin A kit Level Calibrators B064-112-P2

GUDID 06438147344406

Time-resolved fluoroimmunoassay for the quantitative determination of human Inhibin A.

Wallac Oy

Inhibin A IVD, kit, fluorescent immunoassay
Primary Device ID06438147344406
NIH Device Record Keye81e521d-de46-4249-a095-52db0b96269c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutoDELFIA Inhibin A kit Level Calibrators
Version Model NumberB064-112-P2
Catalog NumberB064-112-P2
Company DUNS540156544
Company NameWallac Oy
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -80 Degrees Celsius and -60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106438147344406 [Primary]

FDA Product Code

NDREnzyme Immunoassay, Inhibin-A

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-24
Device Publish Date2018-11-21

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