FDA.reportPublic FDA data

Augurex Life Sciences

Primary DI
06284510990431
Brand
Augurex Life Sciences
Company
Cedarlane Corporation
Model
90-0021
Catalog number
90-0021
Device description
48F10 Anti-Human 14-3-3eta mAb-HRP, Conc 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
06284510990431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06284510990431062845109904316284510990431

GMDN Terms#

Term, Definition table
TermDefinition
Protein 14-3-3 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 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 Temperature-80 Degrees Celsius-80 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
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
00382906718167HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718174HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718181HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718198HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718204HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718211HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718235HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718242HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718259HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718266HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718273HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718280HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718310HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718327HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718334HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718341HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718358Not ApplicableBecton, Dickinson And CompanyMVU2026-09-24
00382906718365HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718372HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718389HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718396HorizonBecton, Dickinson And CompanyMVU2026-09-24
00840542202094Anti-Hepatitis B Virus Core Antigen (HBcAg)BIOGENEX LABORATORIESMVU2026-09-22
00840542202100Anti-Hepatitis B Virus Core Antigen (HBcAg)BIOGENEX LABORATORIESMVU2026-09-22
00840542202117Anti-Hepatitis B Virus Core Antigen (HBcAg)BIOGENEX LABORATORIESMVU2026-09-22
00840542202186Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202193Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202209Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202216Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202223Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202230Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22