FDA.reportPublic FDA data

Augurex Life Sciences

Primary DI
06284510990394
Brand
Augurex Life Sciences
Company
Cedarlane Corporation
Model
90-0038
Catalog number
90-0038
Device description
14-3-3eta Rec. Human, Lyophilized ASR
Published
2022-12-08
Public version status
Update
Distribution status
Not 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
06284510990394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06284510990394062845109903946284510990394

GMDN Terms#

Term, Definition table
TermDefinition
Protein 14-3-3 IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of protein 14-3-3 in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
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
00628451099284Standard Rabbit ComplementCL3002CL30022024-12-11

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