FDA.reportPublic FDA data

Invivoscribe

Primary DI
00810022730867
Brand
Invivoscribe
Company
INVIVOSCRIBE, INC.
Model
810022730867
Catalog number
A4120079
Device description
This analyte specific reagent targets the ITD analyte within the human FLT3 gene.
Published
2022-01-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00810022730867PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810022730867008100227308678100227308670810022730867

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
836976779
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810022732571LeukoStrat00810022732571K41203612023-05-30
00850052003739LeukoStrat850052003739K41203612020-06-08
00810022730638Invivoscribe810022730638A31000302021-02-02
00810022730676Invivoscribe810022730676A31000812021-02-02
00850052003685LeukoStrat850052003685K41202212020-05-29
00810022730744Invivoscribe810022730744A41200092022-01-18
00810022730768Invivoscribe810022730768A41200192022-01-18
00810022730775Invivoscribe810022730775A41200292022-01-18
00810022730805Invivoscribe810022730805A41200392022-01-18
00810022730812Invivoscribe810022730812A41200492022-01-18
00810022730829Invivoscribe810022730829A41200592022-01-18
00810022730843Invivoscribe810022730843A41200692022-01-18
00810022730881Invivoscribe810022730881A41200892022-01-18
00810022730898Invivoscribe810022730898A41200992022-01-18
00810022730911Invivoscribe810022730911A41201192022-01-18
00810022730928Invivoscribe810022730928A41201292022-01-18
00810022730935Invivoscribe810022730935A41201392022-01-18
00810022730942Invivoscribe810022730942A41201492022-01-18
00810022730959Invivoscribe810022730959A41201592022-01-18
00810022730973Invivoscribe810022730973A41201792022-01-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810034702951PerCP/Cyanine5.5 anti-human Beta2-microglobulinBIOLEGEND, INC.MVU2026-06-01
00810034704061PE/Dazzle™ 594 anti-human CD22BIOLEGEND, INC.MVU2026-06-01
00810034704092FITC anti-human CD35BIOLEGEND, INC.MVU2026-06-01
00810034704108PE/Cyanine7 anti-human CD22BIOLEGEND, INC.MVU2026-06-01
00810034704139PE/Cyanine7 anti-human CD300eBIOLEGEND, INC.MVU2026-06-01
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