FDA.reportPublic FDA data

LysoPC IS

Primary DI
06438147392339
Brand
LysoPC IS
Company
Wallac Oy
Model
4417-0010
Catalog number
4417-0010
Device description
N/A
Published
2024-01-08
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
MVUReagents, Specific, Analyte

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438147392339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438147392339064381473923396438147392339

GMDN Terms#

Term, Definition table
TermDefinition
Assay development analyte-specific reagent IVDAn antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological specimen for the development of a laboratory developed test (LDT) or commercial in vitro diagnostic medical device (IVD). Commonly referred to as an analyte specific reagent (ASR), it is neither labelled with instructions for use nor diagnostic or performance claims.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius-16 Degrees Celsius

Regulatory Flags#

DUNS number
540156544
Device count
1
Premarket exempt
true
Kit
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
06438147371815Qsight 210 MD Screening System2040-00102040-00102023-03-29
06438147411672NeoLSD MSMS kit3093-004U3093-004U2025-08-15
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
06438147009336AutoDELFIA hCG kit B007-101B007-1012016-02-11
06438147356218NeoLSD MSMS kit3093-001U3093-001U2018-11-28
06438147064564DELFIA Platewash1296-0261296-0262021-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08595715450544CyFlow™ CD200 PE-Cy7EXBIO Praha, a.s.MVU2025-10-01
08719327450949Anti-HbF PUREIQ Products B.V.MVU2023-01-26
08719327450956Anti-HbF FITCIQ Products B.V.MVU2023-01-26
08719327450963Anti-HbF R-PEIQ Products B.V.MVU2023-01-26
08719327450970Anti-HbF Dy-410IQ Products B.V.MVU2023-01-26
08719327450987anti-HbS PUREIQ Products B.V.MVU2023-01-26
08719327450994anti-HbS FITCIQ Products B.V.MVU2023-01-26
08719327451014CD163 PURE IQ Products B.V.MVU2023-01-26
08719327451021CD163 FITCIQ Products B.V.MVU2023-01-26
08719327451038CD163 R-PEIQ Products B.V.MVU2023-01-26
08719327451045CD163 BiotinIQ Products B.V.MVU2023-01-26
08719327451052CD64 PUREIQ Products B.V.MVU2023-01-26
08719327451069CD64 CyQIQ Products B.V.MVU2023-01-26
08719327451076CD64 FITCIQ Products B.V.MVU2023-01-26
08719327451083CD64 R-PEIQ Products B.V.MVU2023-01-26
08719327451090CD64 R-PEIQ Products B.V.MVU2023-01-26
08436548983413CD38-multi-epitope-FITCCYTOGNOS SLMVU2023-01-17
08436548984946CD45-APC-C750™CYTOGNOS SLMVU2023-01-17
10190302007276PRIMER 100 NMOL LIQ TELIFE TECHNOLOGIES CORPORATIONMVU2018-09-18
10190302007283PRIMER 100 NMOL DRYLIFE TECHNOLOGIES CORPORATIONMVU2018-09-18
10190302009492Mouse IgM Purified AntibodyLIFE TECHNOLOGIES CORPORATIONMVU2018-07-02
10190302009508Mouse IgM FITC ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-07-02
10190302009515Mouse IgM R-PE ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-07-02
10190302010405Human CD14 TRI-COLOR® ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-05-06
10190302010412Human CD14 Biotin ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-05-06
10190302010429Human CD14 PE-Texas Red® ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-05-06
10190302010436Human CD14 PE-Cy®5.5 ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-05-06
10190302010443Human CD14 APC- Alexa Fluor® 750 Conj.LIFE TECHNOLOGIES CORPORATIONMVU2018-05-06
10190302010450Human CD14 Pacific Blue™ ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-05-06
10190302010467Human CD14 Alexa Fluor® 700 ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-05-06