FDA.reportPublic FDA data

LaCAR

Primary DI
05430003908846
Brand
LaCAR
Company
Lacar MDX Technologies
Model
2110
Catalog number
2110
Device description
6-HMU Dilution Set General Purpose Reagent, For Laboratory Use.
Published
2026-01-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PPMGeneral Purpose Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05430003908846PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05430003908846054300039088465430003908846

GMDN Terms#

Term, Definition table
TermDefinition
Newborn metabolic screen/congenital disorder IVD, calibratorA material which is used to establish known points of reference for 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

Regulatory Flags#

DUNS number
371365041
Device count
1
Premarket exempt
true
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
05430003908617SEEKER®120212022026-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00846405012312Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012329Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012411Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012428Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012435Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012459Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012466Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012473Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012497Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012503Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012510Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012527Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012534Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012541Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012558Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012565Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012589Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405013432Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405014163Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405014170Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405014200Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405016730Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405016778Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405017133Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405017140Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405023219Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405023271Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08