AutoDELFIA Neonatal 17α-OH-progesterone kit B024-112

GUDID 06438147292486

For the quantitative determination of 17α-OH-progesterone (17-OHP) in dried blood.

Wallac Oy

17-Hydroxyprogesterone IVD, kit, fluorescent immunoassay
Primary Device ID06438147292486
NIH Device Record Keya57e2204-71ed-42ea-a179-852e371eb23f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutoDELFIA Neonatal 17α-OH-progesterone kit
Version Model NumberB024-112
Catalog NumberB024-112
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 Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106438147292486 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JLXRadioimmunoassay, 17-Hydroxyprogesterone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-17
Device Publish Date2018-11-16

On-Brand Devices [AutoDELFIA Neonatal 17α-OH-progesterone kit]

06438147292523For the quantitative determination of 17α-OH-progesterone (17-OHP) in dried blood.
06438147292486For the quantitative determination of 17α-OH-progesterone (17-OHP) in dried blood.
06438147292479For the quantitative determination of 17α-OH-progesterone (17-OHP) in dried blood.

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