AutoDELFIA Neonatal hTSH kit B032-02C

GUDID 06438147179596

Time-resolved fluoroimmunoassay for the quantitative determination of human thyrotropin (thyroid stimulating hormone - hTSH) in dried blood.

Wallac Oy

Neonatal thyroid stimulating hormone (neonatal TSH) IVD, kit, fluorescent immunoassay
Primary Device ID06438147179596
NIH Device Record Key2156f99f-9445-40d5-80aa-d23441a4bccf
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutoDELFIA Neonatal hTSH kit
Version Model NumberB032-02C
Catalog NumberB032-02C
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
GS106438147179596 [Primary]

FDA Product Code

JLWRadioimmunoassay, Thyroid-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 Date2016-02-02

On-Brand Devices [AutoDELFIA Neonatal hTSH kit]

06438147179596Time-resolved fluoroimmunoassay for the quantitative determination of human thyrotropin (thyroid
06438147140473Time-resolved fluoroimmunoassay for the quantitative determination of human thyrotropin (thyroid

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