Eonis SCID-SMA kit 3241-001U

GUDID 06438147377732

The Eonis SCID-SMA kit is a device intended for PCR amplification of sjTREC, KREC, SMN1 and RPP30 DNAs.

Wallac Oy

Multiple primary immunodeficiency/congenital muscular disorder IVD, kit, nucleic acid technique (NAT)
Primary Device ID06438147377732
NIH Device Record Key36c600ec-87ee-4898-991e-5281f3808c28
Commercial Distribution StatusIn Commercial Distribution
Brand NameEonis SCID-SMA kit
Version Model Number3241-001U
Catalog Number3241-001U
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 Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -30 Degrees Celsius and -16 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -16 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -16 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -16 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -16 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -16 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -16 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -16 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106438147377732 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QUESpinal Muscular Atrophy Newborn Screening Test System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-08
Device Publish Date2022-11-30

On-Brand Devices [Eonis SCID-SMA kit]

06438147377756The Eonis SCID-SMA kit is a device intended for PCR amplification of sjTREC, KREC, SMN1 and RPP3
06438147377732The Eonis SCID-SMA kit is a device intended for PCR amplification of sjTREC, KREC, SMN1 and RPP3

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