FDA.reportPublic FDA data

CA 19-9 AccuBind ELISA Test System - 96 Wells

Primary DI
00816870020518
Brand
CA 19-9 AccuBind ELISA Test System - 96 Wells
Company
MONOBIND, INC.
Model
3925-300
Catalog number
3925-300A
Published
2019-02-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NIGSYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIGSystem, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic CancerImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816870020518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816870020518008168700205188168700205180816870020518

GMDN Terms#

Term, Definition table
TermDefinition
Cancer antigen 19-9 (CA19-9) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 19-9 (CA19-9) in a clinical specimen, using an enzyme immunoassay (EIA) method. CA19-9 is typically used as a marker commonly associated with gastrointestinal, pancreatic, bile duct and gallbladder cancer.

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
Premarket exempt
true
Kit
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
00816870021096Anti-H. Pylori IgM AccuBind ELISA Test System - 96 Wells1525-3001525-300A2019-02-11
00816870021102Anti-H. Pylori IgG AccuBind ELISA Test System - 96 Wells1425-3001425-300A2019-02-11
00816870023441PCT AccuLite CLIA Test System - 96 Wells9275-3009275-300A2024-09-13
00816870023458PCT AccuLite CLIA Test System - 192 Wells9275-3009275-300B2024-09-13
00816870023465PCT AccuBind ELISA Test System - 96 Wells9225-3009225-300A2024-09-13
00816870023472PCT AccuBind ELISA Test System - 192 Wells9225-3009225-300B2024-09-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10758750034833VITROSORTHO CLINICAL DIAGNOSTICSNIG2024-04-25
20758750034830VITROSORTHO CLINICAL DIAGNOSTICSNIG2024-04-25
00630414293516Atellica IM CA 19-9Siemens Healthcare Diagnostics Inc.NIG2020-05-31
14560189213392ST AIA-PACK PROG IITOSOH CORPORATIONNIG2019-07-12
00816870020525CA 19-9 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.NIG2019-02-11
00816870022192CA 19-9 AccuLite CLIA Test System - 96 WellsMONOBIND, INC.NIG2019-02-11
00816870022208CA 19-9 AccuLite CLIA Test System - 192 WellsMONOBIND, INC.NIG2019-02-11
00380740155919AlinityAbbott GmbHNIG2019-01-03
00630414577135ADVIA Centaur® CA 19-9 DILSiemens Healthcare Diagnostics Inc.NIG2018-12-01
00630414598161Atellica IM CA 19-9Siemens Healthcare Diagnostics Inc.NIG2018-02-06
00380740137304ARCHITECTAbbott GmbHNIG2017-12-29
00630414598192Atellica IM CA 19-9 MCMSiemens Healthcare Diagnostics Inc.NIG2017-12-27
00630414598178Atellica IM CA 19-9Siemens Healthcare Diagnostics Inc.NIG2017-12-22
00630414598185Atellica IM CA 19-9 DILSiemens Healthcare Diagnostics Inc.NIG2017-12-22
00380740145392ARCHITECTAbbott GmbHNIG2017-05-01
00380740145408ARCHITECTAbbott GmbHNIG2017-05-01
04015630939640Elecsys CA 19-9Roche Diagnostics GmbHNIG2017-04-14
14560189210209ST AIA-PACK CA 19-9TOSOH CORPORATIONNIG2016-09-24
04560189211124AIA-PACK CA 19-9 Sample Diluting SolutionTOSOH CORPORATIONNIG2016-09-24
00842768028533Dimension Vista® Flex® reagent cartridge CA19-9Siemens Healthcare Diagnostics Inc.NIG2016-09-24
00630414447926ADVIA Centaur® CA 19-9 MCMSiemens Healthcare Diagnostics Inc.NIG2016-09-24
00630414574028ADVIA Centaur® CA 19-9™Siemens Healthcare Diagnostics Inc.NIG2016-09-24
00630414574257ADVIA Centaur® CA 19-9™Siemens Healthcare Diagnostics Inc.NIG2016-09-24
00630414577128ADVIA Centaur® CA 19-9™ DILSiemens Healthcare Diagnostics Inc.NIG2016-09-24
04015630904297Elecsys CA 199 ImmunoassayRoche Diagnostics GmbHNIG2016-09-20
15099590231842Access GI MonitorBeckman Coulter, Inc.NIG2016-09-09
10758750002351VITROSORTHO CLINICAL DIAGNOSTICSNIG2016-08-26
00380740003555ARCHITECTABBOTT LABORATORIESNIG2016-06-06
00380740003562ARCHITECTABBOTT LABORATORIESNIG2016-06-06
00380740105464ARCHITECTABBOTT LABORATORIESNIG2016-06-06