NeoLSD MSMS kit

Primary DI
06438147356218
Brand
NeoLSD MSMS kit
Company
Wallac Oy
Model
3093-001U
Catalog number
3093-001U
Device description
For the quantitative measurement of the activity of certain lysosomal enzymes in dried blood spots.Note: Kit contains multiple packages.
Published
2018-11-28
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
PQWAlpha-D-Galactosidase A (Gla) Newborn Screening Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQWAlpha-D-Galactosidase A (Gla) 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
06438147356218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147356218064381473562186438147356218

GMDN Terms#

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

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Primary DI, Brand, Model table
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06438147292479AutoDELFIA Neonatal 17α-OH-progesterone kitB024-01CB024-01C2018-11-16
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05430003908617SEEKER®Lacar MDX TechnologiesPQW2026-01-15
05430003908716SEEKER®Lacar MDX TechnologiesPQW2026-01-15
06438147411672NeoLSD MSMS kitWallac OyPQW2025-08-15
00819704020111SEEKER™Baebies, Inc.PQW2017-08-04
00819704020173SEEKER™Baebies, Inc.PQW2017-08-04