FDA.reportPublic FDA data

Total PSA AccuLite CLIA Test System - 192 Wells

Primary DI
00816870022307
Brand
Total PSA AccuLite CLIA Test System - 192 Wells
Company
MONOBIND, INC.
Model
2175-300
Catalog number
2175-300B
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
LTJPROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LTJProstate-Specific Antigen (Psa) For Management Of Prostate CancersImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816870022307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816870022307008168700223078168700223070816870022307

GMDN Terms#

Term, Definition table
TermDefinition
Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total prostate specific antigen (tPSA) 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
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
07613336217672Elecsys free PSARoche Diagnostics GmbHLTJ2024-10-24
00630414293738Atellica IM PSASiemens Healthcare Diagnostics Inc.LTJ2020-05-31
00630414294230Atellica IM PSASiemens Healthcare Diagnostics Inc.LTJ2020-05-31
00816870020594Free fPSA AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LTJ2019-02-11
00816870020600Free fPSA AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LTJ2019-02-11
00816870020617Total PSA AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LTJ2019-02-11
00816870020624Total PSA AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LTJ2019-02-11
00816870020631Total PSA Extra Sensitive AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LTJ2019-02-11
00816870020648Total PSA Extra Sensitive AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LTJ2019-02-11
00816870022277Free PSA AccuLite CLIA Test System - 96 WellsMONOBIND, INC.LTJ2019-02-11
00816870022284Monobind AccuLite Free PSA CLIA Kit - 192 WellsMONOBIND, INC.LTJ2019-02-11
00816870022291Total PSA AccuLite CLIA Test System - 96 WellsMONOBIND, INC.LTJ2019-02-11
00816870022314Total PSA Extra Sensitive AccuLite CLIA Test System - 96 WellsMONOBIND, INC.LTJ2019-02-11
00816870022321Total PSA Extra Sensitive AccuLite CLIA Test System - 192 WellsMONOBIND, INC.LTJ2019-02-11
00630414599809Atellica IM PSASiemens Healthcare Diagnostics Inc.LTJ2018-11-14
00630414599816Atellica IM PSASiemens Healthcare Diagnostics Inc.LTJ2018-11-14
00630414599823Atellica IM PSA MCMSiemens Healthcare Diagnostics Inc.LTJ2018-11-14
08809317540481FREND PSA PlusNanoEnTek, Inc.LTJ2018-05-04
30816467020014FastPack® IP Total PSA Kit (90)QUALIGEN INC.LTJ2017-09-14
08809317540184FREND PSA PlusNanoEnTek, Inc.LTJ2016-09-30
10816467020010FastPack® Total PSA Kit (50)QUALIGEN INC.LTJ2016-09-16
20816467020017FastPack® IP Total PSA Kit (30)QUALIGEN INC.LTJ2016-09-16
10758750000319VITROSORTHO CLINICAL DIAGNOSTICSLTJ2016-08-26
10758750001309VITROSORTHO CLINICAL DIAGNOSTICSLTJ2016-08-26
00380740008963ARCHITECTAbbott Ireland DiagnosticsLTJ2014-11-18
00380740008970ARCHITECTAbbott Ireland DiagnosticsLTJ2014-11-18
00380740008987ARCHITECTAbbott Ireland DiagnosticsLTJ2014-11-18
00380740008994ARCHITECTAbbott Ireland DiagnosticsLTJ2014-11-18
14560189212104ST AIA-PACK PATOSOH CORPORATIONLTJ2014-09-24
00630414202952ADVIA Centaur® Systems, ACS 180® Systems PSA MCMSiemens Healthcare Diagnostics Inc.LTJ2014-09-24