FDA.reportPublic FDA data

Eonis SCID-SMA kit

Primary DI
06438147377732
Brand
Eonis SCID-SMA kit
Company
Wallac Oy
Model
3241-001U
Catalog number
3241-001U
Device description
The Eonis SCID-SMA kit is a device intended for PCR amplification of sjTREC, KREC, SMN1 and RPP30 DNAs.
Published
2022-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PJISevere Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
QUESpinal Muscular Atrophy Newborn Screening Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJISevere Combined Immunodeficiency Disorder (Scid) Newborn Screening Test SystemImmunology2
QUESpinal Muscular Atrophy Newborn Screening Test SystemImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN200044000
K203035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN200044000Eonis SCID-SMA KitPerkinelmer, Inc.2022-11-09QUE
K203035000Eonis SCID-SMA kitPerkinelmer, Inc.2022-11-09PJI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438147377732PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147377732064381473777326438147377732

GMDN Terms#

Term, Definition table
TermDefinition
Multiple primary immunodeficiency/congenital muscular disorder IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict multiple inborn immunodeficiencies [e.g., X-linked agammaglobulinaemia, severe combined immunodeficiency (SCID)] and congenital muscular disorders (e.g., spinal muscular atrophy) using a nucleic acid technique (NAT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius-16 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
540156544
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06438147371815Qsight 210 MD Screening System2040-00102040-00102023-03-29
06438147411672NeoLSD MSMS kit3093-004U3093-004U2025-08-15
06438147179596AutoDELFIA Neonatal hTSH kitB032-02CB032-02C2016-02-02
06438147179602AutoDELFIA Neonatal Thyroxine (T4) kitB065-01CB065-01C2016-02-02
06438147292479AutoDELFIA Neonatal 17α-OH-progesterone kitB024-01CB024-01C2018-11-16
06438147344406AutoDELFIA Inhibin A kit Level Calibrators B064-112-P2B064-112-P22018-11-21
06438147344420AutoDELFIA Inhibin A kit B064-112B064-1122017-10-10
06438147355037AutoDELFIA Unconjugated Estriol (uE3) kitB095-112B095-1122018-11-16
06438147377756Eonis SCID-SMA kit3242-001U3242-001U2022-11-30
06438147121373VICTOR2 D1420-0211420-0212019-03-19
06438147333202VICTOR EnLite1420-02201420-02202019-03-19
06438147333219VICTOR EnLite1420-02301420-02302019-03-19
06438147064540Wallac Plate Shake1296-0041296-0042019-02-25
06438147009176DELFIA hCG kitA007-101A007-1012016-02-11
06438147009343AutoDELFIA hCG kitB007-112B007-1122016-02-11
06438147391998DBS Controls LysoPC3413-00103413-00102024-01-08
06438147392339LysoPC IS4417-00104417-00102024-01-08
06438147009336AutoDELFIA hCG kit B007-101B007-1012016-02-11
06438147356218NeoLSD MSMS kit3093-001U3093-001U2018-11-28
06438147064564DELFIA Platewash1296-0261296-0262021-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06438147377756Eonis SCID-SMA kitWallac OyPJI2022-11-30
06438147377756Eonis SCID-SMA kitWallac OyQUE2022-11-30
06438147331802EnLite Neonatal TREC kitWallac OyPJI2016-02-02
06438147331819EnLite Neonatal TREC kitWallac OyPJI2016-02-02
06438147331826EnLite Neonatal TREC kitWallac OyPJI2016-02-02