FDA.reportPublic FDA data

Monobind AccuLite CA 125 CLIA Kit - 96 Wells

Primary DI
00816870022154
Brand
Monobind AccuLite CA 125 CLIA Kit - 96 Wells
Company
MONOBIND, INC.
Model
3075-300
Catalog number
3075-300A
Published
2019-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LTKTEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LTKTest, Epithelial Ovarian Tumor-Associated Antigen (Ca125)Immunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816870022154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816870022154008168700221548168700221540816870022154

GMDN Terms#

Term, Definition table
TermDefinition
Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 125 (CA125), a marker commonly associated with ovarian cancer, in a clinical specimen using a chemiluminescent immunoassay method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width7.75Inch

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(949)951-2665info@monobind.com

Regulatory Flags#

DUNS number
083155515
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816870020006NeoLumax CLIA AnalyzerIN010IN0102024-09-13
00816870020013LuMatic CLIA AnalyzerIN008IN0082024-09-13
00816870020044Immunoassay Plate WasherIN002IN0022024-09-13
00816870020051NeoEldex ELISA AnalyzerIN009IN0092024-09-13
00816870020068PrisMatic ELISA AnalyzerIN013IN0132024-09-13
00816870020075Autoplex G1 ELISA AnalyzerIN006IN0062024-09-13
00816870020082Autoplex G2 ELISA + CLIA AnalyzerIN006-2IN006-22024-09-13
00816870020402PTH Intact AccuBind ELISA Test System - 96 Wells9025-3009025-300A2024-09-13
00816870021010PAPP-A AccuBind ELISA Test System - 192 Wells12625-30012625-300B2024-09-13
00816870021164N-17-OHP AccuBind ELISA Test System - 96 Wells5525-3005525-300A2024-09-13
00816870021171N-17-OHP AccuBind ELISA Test System - 192 Wells5525-3005525-300B2024-09-13
00816870021188N-17-OHP AccuBind ELISA Test System - 480 Wells5525-3005525-300D2024-09-13
00816870021195N-17-OHP AccuBind ELISA Test System - 960 Wells5525-3005525-300E2024-09-13
00816870021201N-17-OHP AccuBind ELISA Test System - 1920 Wells5525-3005525-300F2024-09-13
00816870021294903 DBS Collection Cards - 6 Samples329MM329MM2024-09-13
00816870021300903 DBS Collection Cards - 5 Samples621MM621MM2024-09-13
00816870022642PAPP-A AccuLite CLIA Test System - 96 Wells12675-30012675-300A2024-09-13
00816870022659PAPP-A AccuLite CLIA Test System - 192 Wells12675-30012675-300B2024-09-13
00816870023366Vit D Direct AccuLite CLIA Test System - 96 wells9475-3009475-300A2024-09-13
00816870023373Vit D Direct AccuLite CLIA Test System - 192 wells9475-3009475-300B2024-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336218327Elecsys CA 125 IIRoche Diagnostics GmbHLTK2024-08-13
10758750034826VITROSORTHO CLINICAL DIAGNOSTICSLTK2023-03-14
10758750034901VITROSORTHO CLINICAL DIAGNOSTICSLTK2023-03-14
00630414294278Atellica IM CA 125IISiemens Healthcare Diagnostics Inc.LTK2020-05-31
00380740131043AlinityAbbott GmbH & Co. KGLTK2019-02-12
00816870020471Monobind AccuBind CA 125 ELISA Kit - 96 WellsMONOBIND, INC.LTK2019-02-11
00816870020488Monobind AccuBind CA 125 ELISA Kit - 192 WellsMONOBIND, INC.LTK2019-02-11
00816870022161Monobind AccuLite CA 125 CLIA Kit - 192 WellsMONOBIND, INC.LTK2019-02-11
00380740145361ARCHITECTAbbott GmbH & Co. KGLTK2019-01-21
00380740145378ARCHITECTAbbott GmbH & Co. KGLTK2019-01-21
00380740145385ARCHITECTAbbott GmbH & Co. KGLTK2019-01-21
00380740131050AlinityAbbott GmbH & Co. KGLTK2018-12-31
00630414598116Atellica IM CA 125II MCMSiemens Healthcare Diagnostics Inc.LTK2017-12-27
00630414598086Atellica IM CA 125IISiemens Healthcare Diagnostics Inc.LTK2017-12-22
00630414598093Atellica IM CA 125IISiemens Healthcare Diagnostics Inc.LTK2017-12-22
00630414598109Atellica IM CA 125II CalibratorSiemens Healthcare Diagnostics Inc.LTK2017-12-22
14560189210216ST AIA-PACK CA 125TOSOH CORPORATIONLTK2016-09-24
04560189211131AIA-PACK CA 125 Sample Diluting SolutionTOSOH CORPORATIONLTK2016-09-24
04560189211148AIA-PACK CA 125 Calibrator SetTOSOH CORPORATIONLTK2016-09-24
00842768028519Dimension Vista® Flex® reagent cartridge CA125Siemens Healthcare Diagnostics Inc.LTK2016-09-24
00630414461274ADVIA Centaur® CA 125II MCMSiemens Healthcare Diagnostics Inc.LTK2016-09-24
00630414461298ADVIA Centaur® CA 125IISiemens Healthcare Diagnostics Inc.LTK2016-09-24
00630414461304ADVIA Centaur® CA 125 IISiemens Healthcare Diagnostics Inc.LTK2016-09-24
00630414461335ADVIA Centaur® Systems CA 125II CalibratorSiemens Healthcare Diagnostics Inc.LTK2016-09-24
00630414954127IMMULITE®/IMMULITE® 1000 Systems OMM OM-MA Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLTK2016-09-24
00630414954134IMMULITE® 2000 Systems OM-MA Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLTK2016-09-24
00630414954219IMMULITE®/IMMULITE® 1000 Systems RTH Rapid TSH Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLTK2016-09-24
00630414961798IMMULITE® 2000 Systems OV OM-MA (CA125)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLTK2016-09-24
00630414964331IMMULITE®/IMMULITE® 1000 Systems OV OM-MA (CA 125)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLTK2016-09-24
04987270234273Lumipulse G CA125II Immunoreaction CartridgesFUJIREBIO INC.LTK2016-09-16