FDA.reportPublic FDA data

Invivoscribe

Primary DI
00810022730348
Brand
Invivoscribe
Company
INVIVOSCRIBE, INC.
Model
810022730348
Catalog number
A1020021
Device description
Analyte specific reagent targets the variable, the Kde, and the intragenic regions within the human immunoglobulin kappa light chain locus.
Published
2020-10-21
Public version status
Update
Distribution status
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
00810022730348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810022730348008100227303488100227303480810022730348

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
00810022730867Invivoscribe810022730867A41200792022-01-18
00810022730881Invivoscribe810022730881A41200892022-01-18
00810022730898Invivoscribe810022730898A41200992022-01-18
00810022730911Invivoscribe810022730911A41201192022-01-18
00810022730928Invivoscribe810022730928A41201292022-01-18
00810022730935Invivoscribe810022730935A41201392022-01-18
00810022730942Invivoscribe810022730942A41201492022-01-18
00810022730959Invivoscribe810022730959A41201592022-01-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810227730006Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730013Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730020Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730037Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429967Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429974Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429981Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429998Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730044Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730051Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730068Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730136Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730143Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730150Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730228Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
05055844935792CytoCell myProbesCYTOCELL LIMITEDMVU2026-07-19
00810227730198Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-13
00810227730204Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-13
00810034704306Spark Violet™ 538 anti-human CD4BIOLEGEND, INC.MVU2026-07-06
00810034704337Spark Violet™ 423 anti-human CD45BIOLEGEND, INC.MVU2026-07-06
15099590807160Anti-TCR Cß1 (TRBC1)-FITCIMMUNOTECHMVU2026-06-25
05055844935761CytoCell myProbesCYTOCELL LIMITEDMVU2026-06-06
05055844935778CytoCell myProbesCYTOCELL LIMITEDMVU2026-06-06
00810034704085FITC anti-human Granzyme BBIOLEGEND, INC.MVU2026-06-05
00810034704146PE/Cyanine7 anti-human Granzyme BBIOLEGEND, INC.MVU2026-06-05
00810034704160APC anti-human CD64BIOLEGEND, INC.MVU2026-06-05
00810034704177FITC anti-human CD69BIOLEGEND, INC.MVU2026-06-05
00810034704191PE/Cyanine7 anti-human CD69BIOLEGEND, INC.MVU2026-06-05
00810034704214APC anti-human CD31BIOLEGEND, INC.MVU2026-06-05
00810034704245APC anti-human CD274BIOLEGEND, INC.MVU2026-06-05