FDA.reportPublic FDA data

ASR

Primary DI
00543000390882
Brand
ASR
Company
Lacar MDX Technologies
Model
3640
Catalog number
3951
Device description
4-MU IDS Reagent Tube, 4.3mL Analyte Specific Reagent - Analytical and performance characteristics are not established.
Published
2026-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVUReagents, Specific, Analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05430003908839PackageGS112In Commercial Distribution
00543000390882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
05430003908839054300039088395430003908839
00543000390882005430003908825430003908820543000390882

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

Contacts#

Phone, Email table
PhoneEmail
+32042873944customer@lacar-mdx.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
05430003908617SEEKER®120212022026-01-15
05430003908624SEEKER®120312032026-01-15

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