FDA.reportPublic FDA data

FLAER

Primary DI
00628451099352
Brand
FLAER
Company
Cedarlane Corporation
Model
FL1S
Catalog number
FL1S
Device description
FLAER (Alexa 488 proaerolysin variant) liquid format-ASR
Published
2024-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
06284510990356PreviousGS10
00628451099352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
06284510990356062845109903566284510990356
00628451099352006284510993526284510993520628451099352

GMDN Terms#

Term, Definition table
TermDefinition
Fluorescein-labelled aerolysin (FLAER) test IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of glycophosphatidylinositol-deficient blood cells from a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight25Microgram

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
243928822
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06284510990387Augurex Life Sciences90-000590-00052022-12-08
06284510990394Augurex Life Sciences90-003890-00382022-12-08
06284510990400Augurex Life Sciences90-002090-00202022-12-08
06284510990417Augurex Life Sciences90-000990-00092022-12-08
06284510990431Augurex Life Sciences90-002190-00212022-12-08
06284510990448Augurex Life Sciences90-003190-00312022-12-08
06284510990455Augurex Life Sciences90-001390-00132022-12-08
06284510990462Augurex Life Sciences90-001590-00152022-12-08
06284510990479Augurex Life Sciences90-001690-00162022-12-08
00628451099062Standard Rabbit ComplementCL3001CL30012024-12-11
00628451099079Standard Rabbit Complement, FrozenCL3005CL30052024-12-11
00628451099086Standard Rabbit ComplementCL3010-10CL3010-102024-12-11
00628451099093Standard Rabbit ComplementCL3010CL30102024-12-11
00628451099109Standard Rabbit ComplementCL3025CL30252024-12-11
00628451099116Standard Rabbit ComplementCL3050CL30502024-12-11
00628451099123Standard Rabbit ComplementCL3111CL31112024-12-11
00628451099130Standard Rabbit ComplementCL3112CL31122024-12-11
00628451099147Standard Rabbit ComplementCL3113CL31132024-12-11
00628451099154Standard Rabbit ComplementCL3115CL31152024-12-11
00628451099161Standard Rabbit ComplementCL3120CL31202024-12-11

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