AutoDELFIA Neonatal IRT kit B005-204

GUDID 06438147298785

For the quantitative determination of immunoreactive trypsin (IRT) in dried blood.

Wallac Oy

Neonatal trypsin IVD, kit, fluorescent immunoassay
Primary Device ID06438147298785
NIH Device Record Key74faf6be-cecf-4296-b029-e01566be37fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutoDELFIA Neonatal IRT kit
Version Model NumberB005-204
Catalog NumberB005-204
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
GS106438147298785 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JNON-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin

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 Date2016-02-02

On-Brand Devices [AutoDELFIA Neonatal IRT kit ]

06438147298785For the quantitative determination of immunoreactive trypsin (IRT) in dried blood.
06438147298716For the quantitative determination of immunoreactive trypsin (IRT) in dried blood.

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