GSP Neonatal hTSH kit 3301-001U

GUDID 06438147312009

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 ID06438147312009
NIH Device Record Keyd0714bc4-ea2c-4f68-ac46-5b685e85e759
Commercial Distribution StatusIn Commercial Distribution
Brand NameGSP Neonatal hTSH kit
Version Model Number3301-001U
Catalog Number3301-001U
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
GS106438147312009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-01-12

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