AutoDELFIA hCG kit B007-101

GUDID 06438147009336

Time-resolved fluoroimmunoassay for the quantitative determination of human chorionic gonadotropin (hCG).

Wallac Oy

Total human chorionic gonadotropin (HCG) IVD, kit, fluorescent immunoassay
Primary Device ID06438147009336
NIH Device Record Key9a95d0f2-4d10-4475-9ff7-a8e9f13cb5f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutoDELFIA hCG kit
Version Model NumberB007-101
Catalog NumberB007-101
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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106438147009336 [Primary]

FDA Product Code

JHJAgglutination Method, Human Chorionic Gonadotropin

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

On-Brand Devices [AutoDELFIA hCG kit ]

06438147009343Time-resolved fluoroimmunoassay for the quantitative determination of human chorionic gonadotrop
06438147009336Time-resolved fluoroimmunoassay for the quantitative determination of human chorionic gonadotrop

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