FDA.reportPublic FDA data

Monobind AccuLite CEA Next Generation CLIA Kit - 192 Wells

Primary DI
00816870022246
Brand
Monobind AccuLite CEA Next Generation CLIA Kit - 192 Wells
Company
MONOBIND, INC.
Model
4675-300
Catalog number
4675-300B
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
DHXSYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHXSystem, Test, Carcinoembryonic AntigenImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816870022246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816870022246008168700222468168700222460816870022246

GMDN Terms#

Term, Definition table
TermDefinition
Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of carcinoembryonic antigen (CEA) 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
Special Storage Condition, Specify00Handling Environment Temperature

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
20758750034304VITROSORTHO CLINICAL DIAGNOSTICSDHX2024-01-20
00630414294131Atellica IM CEASiemens Healthcare Diagnostics Inc.DHX2020-05-31
14560189212241AIA-PACK CEA Calibration Verification Test SetTOSOH CORPORATIONDHX2019-07-25
00816870020532Monobind AccuBind CEA ELISA Kit - 96 WellsMONOBIND, INC.DHX2019-02-11
00816870020549Monobind AccuBind CEA ELISA Kit - 192 WellsMONOBIND, INC.DHX2019-02-11
00816870020556Monobind AccuBind CEA Next Generation ELISA Kit - 96 WellsMONOBIND, INC.DHX2019-02-11
00816870020563Monobind AccuBind CEA Next Generation ELISA Kit - 192 WellsMONOBIND, INC.DHX2019-02-11
00816870022215Monobind AccuLite CEA CLIA Kit - 96 WellsMONOBIND, INC.DHX2019-02-11
00816870022222Monobind AccuLite CEA CLIA Kit - 192 WellsMONOBIND, INC.DHX2019-02-11
00816870022239Monobind AccuLite CEA Next Generation CLIA Kit - 96 WellsMONOBIND, INC.DHX2019-02-11
00380740130831AlinityAbbott Ireland DiagnosticsDHX2018-12-31
00380740130848AlinityAbbott Ireland DiagnosticsDHX2018-12-31
00380740130855AlinityAbbott Ireland DiagnosticsDHX2018-12-31
00380740130862AlinityAbbott Ireland DiagnosticsDHX2018-12-31
00630414598505Atellica IM CEASiemens Healthcare Diagnostics Inc.DHX2018-02-06
00630414598536Atellica IM CEA MCMSiemens Healthcare Diagnostics Inc.DHX2018-02-06
00630414598529Atellica IM CEA DILSiemens Healthcare Diagnostics Inc.DHX2017-12-27
00630414598512Atellica IM CEASiemens Healthcare Diagnostics Inc.DHX2017-12-22
14560189210780ST AIA-PACK CEATOSOH CORPORATIONDHX2016-09-24
04560189211780AIA-PACK CEA Sample Diluting SolutionTOSOH CORPORATIONDHX2016-09-24
00842768019920Dimension Vista® Flex® reagent cartridge CEASiemens Healthcare Diagnostics Inc.DHX2016-09-24
00630414126302ADVIA Centaur® CEA MCMSiemens Healthcare Diagnostics Inc.DHX2016-09-24
00630414175317ADVIA Centaur® CEA DiluentSiemens Healthcare Diagnostics Inc.DHX2016-09-24
00630414177304ADVIA Centaur® CEASiemens Healthcare Diagnostics Inc.DHX2016-09-24
00630414177311ADVIA Centaur® CEASiemens Healthcare Diagnostics Inc.DHX2016-09-24
00630414204741ADVIA Centaur® CEASiemens Healthcare Diagnostics Inc.DHX2016-09-24
00630414953625IMMULITE®/IMMULITE® 1000 Systems CEA CEA Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDDHX2016-09-24
00630414961118IMMULITE® 2000 Systems CEASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDDHX2016-09-24
00630414961125IMMULITE® 2000 Systems CEASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDDHX2016-09-24
00630414963693IMMULITE®/IMMULITE® 1000 Systems CEASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDDHX2016-09-24