FDA.reportPublic FDA data

NeoLSD MSMS kit

Primary DI
06438147411672
Brand
NeoLSD MSMS kit
Company
Wallac Oy
Model
3093-004U
Catalog number
3093-004U
Device description
For the quantitative measurement of the activity of certain lysosomal enzymes in dried blood spots.Note: Kit contains multiple packages.
Published
2025-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PQTAlpha-L-Iduronidase (Idua) Newborn Screening Test System
PQUAlpha-D-Glucosidase (Gaa) Newborn Screening Test System
PQVß-Glucocerebrosidase (Gba) Newborn Screening Test System
PQWAlpha-D-Galactosidase A (Gla) Newborn Screening Test System
QCLAcid-Sphingomyelinase (Asm) Newborn Screening Test System
QCMß-Galactocerebrosidase (Galc) Newborn Screening Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQTAlpha-L-Iduronidase (Idua) Newborn Screening Test SystemClinical Chemistry2
PQUAlpha-D-Glucosidase (Gaa) Newborn Screening Test SystemClinical Chemistry2
PQVß-Glucocerebrosidase (Gba) Newborn Screening Test SystemClinical Chemistry2
PQWAlpha-D-Galactosidase A (Gla) Newborn Screening Test SystemClinical Chemistry2
QCLAcid-Sphingomyelinase (Asm) Newborn Screening Test SystemClinical Chemistry2
QCMß-Galactocerebrosidase (Galc) Newborn Screening Test SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173829000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173829000NeoLSD MSMS kitWallac Oy, A Subsidiary of Perkinelmer2018-07-18PQW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438147411672PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147411672064381474116726438147411672

GMDN Terms#

Term, Definition table
TermDefinition
Newborn metabolic screen/congenital disorder IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening of a clinical specimen for one or more congenital or metabolic disorders of the newborn, using a spectrophotometry method. It typically utilizes whole-blood neonate specimens dried on filter paper, and the analytes detected may include neonatal thyroxine (neonatal T4), neonatal thyroid stimulating hormone (neonatal TSH), 17-hydroxyprogesterone, immunoreactive trypsinogen, and various enzymes and/or amino acids, as indicators of congenital hypothyroidism, adrenal hyperplasia, cystic fibrosis, lysosomal storage disorders (LSDs), or other metabolic disorders.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius-16 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius30 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
06438147332205chemagic Prepito -D2022-00202022-00202019-02-25
06438147356706chemagic 360-D2024-00102024-00102019-02-25
06438147371815Qsight 210 MD Screening System2040-00102040-00102023-03-29
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
06438147377732Eonis SCID-SMA kit3241-001U3241-001U2022-11-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05430003908594SEEKER®Lacar MDX TechnologiesPQT2026-01-15
05430003908600SEEKER®Lacar MDX TechnologiesPQU2026-01-15
05430003908617SEEKER®Lacar MDX TechnologiesPQW2026-01-15
05430003908624SEEKER®Lacar MDX TechnologiesPQV2026-01-15
05430003908716SEEKER®Lacar MDX TechnologiesPQW2026-01-15
05430003908716SEEKER®Lacar MDX TechnologiesPQV2026-01-15
05430003908716SEEKER®Lacar MDX TechnologiesPQU2026-01-15
05430003908716SEEKER®Lacar MDX TechnologiesPQT2026-01-15
05430003908990SEEKER®Lacar MDX TechnologiesPQT2026-01-15
05430003908990SEEKER®Lacar MDX TechnologiesPQU2026-01-15
06438147356218NeoLSD MSMS kitWallac OyPQW2018-11-28
00819704020081SEEKER™Baebies, Inc.PQU2017-08-04
00819704020098SEEKER™Baebies, Inc.PQT2017-08-04
00819704020104SEEKER™Baebies, Inc.PQV2017-08-04
00819704020111SEEKER™Baebies, Inc.PQW2017-08-04
00819704020173SEEKER™Baebies, Inc.PQT2017-08-04
00819704020173SEEKER™Baebies, Inc.PQV2017-08-04
00819704020173SEEKER™Baebies, Inc.PQU2017-08-04
00819704020173SEEKER™Baebies, Inc.PQW2017-08-04
00819704020180SEEKER™Baebies, Inc.PQU2017-08-04
00819704020180SEEKER™Baebies, Inc.PQT2017-08-04