FDA.reportPublic FDA data

AFP, CEA, PSA Cancer Panel AccuBind VAST ELISA Test System - 960 Wells

Primary DI
00816870020440
Brand
AFP, CEA, PSA Cancer Panel AccuBind VAST ELISA Test System - 960 Wells
Company
MONOBIND, INC.
Model
8425-300
Catalog number
8425-300E
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
LOJKIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOJKit, Test,Alpha-Fetoprotein For Testicular CancerImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816870020440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816870020440008168700204408168700204400816870020440

GMDN Terms#

Term, Definition table
TermDefinition
Alpha-fetoprotein (AFP) IVD, kit, radioimmunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alpha-fetoprotein (AFP) in a clinical specimen, using a radioimmunoassay method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width12Inch

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
07613336217146Elecsys AFPRoche Diagnostics GmbHLOJ2024-10-22
07613336172025Elecsys AFPRoche Diagnostics GmbHLOJ2022-12-07
07613336206157Elecsys AFPRoche Diagnostics GmbHLOJ2022-12-06
07613336206164Elecsys AFPRoche Diagnostics GmbHLOJ2022-12-06
10758750034819VITROSORTHO CLINICAL DIAGNOSTICSLOJ2022-10-24
00630414293561Atellica IM Calibrator DSiemens Healthcare Diagnostics Inc.LOJ2020-05-31
00816870020426Monobind AccuBind AFP, CEA & PSA VAST ELISA Kit - 192 WellsMONOBIND, INC.LOJ2019-02-11
00816870020433AFP, CEA, PSA Cancer Panel AccuBind VAST ELISA Test System - 480 WellsMONOBIND, INC.LOJ2019-02-11
00816870020457AFP AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LOJ2019-02-11
00816870020464AFP AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LOJ2019-02-11
00816870020884AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 192 WellsMONOBIND, INC.LOJ2019-02-11
00816870020891AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 480 WellsMONOBIND, INC.LOJ2019-02-11
00816870021843AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 96 WellsMONOBIND, INC.LOJ2019-02-11
00816870022109AFP, CEA, PSA Cancer Panel AccuLite VAST CLIA Test System - 192 WellsMONOBIND, INC.LOJ2019-02-11
00816870022116AFP, CEA, PSA Cancer Panel AccuLite VAST CLIA Test System - 480 WellsMONOBIND, INC.LOJ2019-02-11
00816870022123AFP, CEA, PSA Cancer Panel AccuLite VAST CLIA Test System - 960 WellsMONOBIND, INC.LOJ2019-02-11
00816870022130AFP AccuLite CLIA Test System - 96 WellsMONOBIND, INC.LOJ2019-02-11
00816870022147Monobind AccuLite AFP CLIA Kit - 192 WellsMONOBIND, INC.LOJ2019-02-11
00816870022543Monobind AccuLite AFP, hCG & uE3 VAST CLIA Kit - 192 WellsMONOBIND, INC.LOJ2019-02-11
00816870022550AFP, hCG, uE3 Triple Screen Panel AccuLite VAST CLIA Test System - 480 WellsMONOBIND, INC.LOJ2019-02-11
00816870023281AFP, hCG, uE3 Triple Screen Panel AccuLite VAST CLIA Test System - 96 WellsMONOBIND, INC.LOJ2019-02-11
00630414598369Atellica IM Calibrator DSiemens Healthcare Diagnostics Inc.LOJ2017-12-27
00630414598376Atellica IM Calibrator DSiemens Healthcare Diagnostics Inc.LOJ2017-12-27
04015630939909Elecsys AFPRoche Diagnostics GmbHLOJ2017-04-14
14560189210230ST AIA-PACK AFPTOSOH CORPORATIONLOJ2016-09-24
04560189211162AIA-PACK AFP Sample Diluting SolutionTOSOH CORPORATIONLOJ2016-09-24
00842768019937Dimension Vista® Flex® reagent cartridge AFPSiemens Healthcare Diagnostics Inc.LOJ2016-09-24
04015630920716Elecsys AFP AssayRoche Diagnostics GmbHLOJ2016-09-20
04015630938810Elecsys AFP AssayRoche Diagnostics GmbHLOJ2016-09-20
10758750000876VITROSORTHO CLINICAL DIAGNOSTICSLOJ2016-08-26