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
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03661540953187DSQ Alert HT Adenovirus Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953217DSQ Alert Hepatitis E Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953224DSQ Alert Hepatitis E Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953279DSQ Alert Mycoplasma pneumoniae Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953286DSQ Alert Mycoplasma pneumoniae Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
00810034704252FITC anti-human TNF-AlphaBIOLEGEND, INC.MVU2026-07-28
00810034704320PE anti-human IL-2BIOLEGEND, INC.MVU2026-07-28
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05055844935792CytoCell myProbesCYTOCELL LIMITEDMVU2026-07-19