FDA.reportPublic FDA data

SEEKER®

Primary DI
05430003908617
Brand
SEEKER®
Company
Lacar MDX Technologies
Model
1202
Catalog number
1202
Device description
SEEKER® GLA Reagent (alpha-D-galactosidase)
Published
2026-01-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
DEN150035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN150035000SEEKER SystemBaebies, Inc.2017-02-03PQW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05430003908617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05430003908617054300039086175430003908617

GMDN Terms#

Term, Definition table
TermDefinition
Newborn metabolic screen/congenital disorder IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay intended to be used in screening a clinical specimen for one or more congenital or metabolic disorders of the newborn. 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-80 Degrees Celsius-70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+3202873944customer@lacar-mdx.com

Regulatory Flags#

DUNS number
371365041
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00543000390882ASR364039512026-04-10
05430003908747ASR210321032026-04-10
05430003908464SEEKER®130531412026-01-15
05430003908587SEEKER®030531402026-01-15
05430003908686SEEKER®080225732026-01-15
05430003908723LaCAR367339532026-01-15
05430003908778LaCAR 395239522026-01-15
05430003908792LaCAR210537252026-01-15
05430003908877LaCAR 211437262026-01-15
05430003908471SEEKER®130531412026-01-15
05430003908518LaCAR097409742026-01-15
05430003908525LaCAR09752026-01-15
05430003908532LaCAR09762026-01-15
05430003908549LaCAR09772026-01-15
05430003908556LaCAR336933692026-01-15
05430003908563SEEKER®341634162026-01-15
05430003908693SEEKER®030531402026-01-15
05430003908594SEEKER®120012002026-01-15
05430003908600SEEKER®120112012026-01-15
05430003908624SEEKER®120312032026-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05430003908716SEEKER®Lacar MDX TechnologiesPQW2026-01-15
06438147411672NeoLSD MSMS kitWallac OyPQW2025-08-15
06438147356218NeoLSD MSMS kitWallac OyPQW2018-11-28
00819704020111SEEKER™Baebies, Inc.PQW2017-08-04
00819704020173SEEKER™Baebies, Inc.PQW2017-08-04