DELFIA hLH Spec kit A031-101

GUDID 06438147009206

Time-resolved fluoroimmunoassay for the quantitative determination of human luteinizing hormone (hLH).

Wallac Oy

Luteinizing hormone (LH) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID06438147009206
NIH Device Record Keyd5e789b9-ba8d-494a-9706-12583b90944e
Commercial Distribution StatusIn Commercial Distribution
Brand NameDELFIA hLH Spec kit
Version Model NumberA031-101
Catalog NumberA031-101
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
GS106438147009206 [Primary]

FDA Product Code

CEPRadioimmunoassay, Luteinizing 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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