FDA.reportPublic FDA data

Kappa-APC

Primary DI
08436548983505
Brand
Kappa-APC
Company
CYTOGNOS SL
Model
CYT-KAPPAP-A
Catalog number
CYT-KAPPAP-A
Device description
Kappa-APC
Published
2022-09-23
Public version status
New
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
08436548983505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436548983505084365489835058436548983505

GMDN Terms#

Term, Definition table
TermDefinition
Kappa/lambda light chain immunoglobulin IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of kappa and/or lambda light chain immunoglobulins in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
563942887
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
08436548983413CD38-multi-epitope-FITCCYT-38F2-500-ACYT-38F2-500-A2023-01-17
08436548984946CD45-APC-C750™CYT-45AC750-500-ACYT-45AC750-500-A2023-01-17
08436548983352CD38-multi-epitope-FITCCYT-38F2-ACYT-38F2-A2022-09-23
08436548983369CD38-FITCCYT-38F-ACYT-38F-A2022-09-23
08436548983376CD38-APC-C750™CYT-38AC750-ACYT-38AC750-A2022-09-23
08436548983390CD138-PE CYT-138PE4-ACYT-138PE4-A2022-09-23
08436548983406CD19-PE-Cyanine7 CYT-19C4-ACYT-19C4-A2022-09-23
08436548983437CD3-APC-C750™CYT-3AC750-ACYT-3AC750-A2022-09-23
08436548983444CD45-APC-C750™CYT-45AC750-ACYT-45AC750-A2022-09-23
08436548983468CD45-OC515™CYT-45OC-ACYT-45OC-A2022-09-23
08436548983475CD56-PECYT-56PE-ACYT-56PE-A2022-09-23
08436548983499CD81-APC-C750™ CYT-81AC750-ACYT-81AC750-A2022-09-23
08436548983512Lambda-APC-C750™CYT-LAC750-ACYT-LAC750-A2022-09-23
08436548983529MPO-FITC CYT-MPOF3-ACYT-MPOF3-A2022-09-23
08436548983543CD15-FITC CYT-15F4-ACYT-15F4-A2022-09-23
08436548983659Lambda-PECYT-LAMBPE-ACYT-LAMBPE-A2022-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00810034704290APC/Fire™ 750 anti-human CD69BIOLEGEND, INC.MVU2026-06-05
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