FDA.reportPublic FDA data

PTH Intact AccuLite CLIA Test System - 192 Wells

Primary DI
00816870024523
Brand
PTH Intact AccuLite CLIA Test System - 192 Wells
Company
MONOBIND, INC.
Model
9075-300
Catalog number
9075-300B
Published
2024-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CEWRADIOIMMUNOASSAY, PARATHYROID HORMONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEWRadioimmunoassay, Parathyroid HormoneClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816870024523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816870024523008168700245238168700245230816870024523

GMDN Terms#

Term, Definition table
TermDefinition
Parathyroid hormone (PTH) 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 parathyroid hormone (PTH) [intact, whole, or truncated fragments] in a clinical specimen, using an enzyme immunoassay (EIA) 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
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
00816870020402PTH Intact AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CEW2024-09-13
00816870023731PTH Whole & Intact AccuLite VAST CLIA Test System - 192 WellsMONOBIND, INC.CEW2024-09-13
00816870023748PTH Whole & Intact AccuLite VAST CLIA Test System - 96 WellsMONOBIND, INC.CEW2024-09-13
00816870023755PTH Whole & Intact AccuBind VAST ELISA Test System - 192 WellsMONOBIND, INC.CEW2024-09-13
00816870023762PTH Whole & Intact AccuBind VAST ELISA Test System - 96 WellsMONOBIND, INC.CEW2024-09-13
00816870024516PTH Intact AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CEW2024-09-13
07613336170304Elecsys PTHRoche Diagnostics GmbHCEW2024-07-30
07613336217542Elecsys PTHRoche Diagnostics GmbHCEW2024-07-30
07613336224922Elecsys PTHRoche Diagnostics GmbHCEW2024-07-30
07613336224939Elecsys PTH STATRoche Diagnostics GmbHCEW2024-07-30
10758750032709VITROSORTHO CLINICAL DIAGNOSTICSCEW2024-01-20
20758750032706VITROSORTHO CLINICAL DIAGNOSTICSCEW2024-01-20
04048474036459PTH (Parathyroid) Intact ELISADRG Instruments Gesellschaft mit beschränkter HaftungCEW2023-08-31
00630414954035IMMULITE® 2000 Systems INS Insulin Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCEW2020-09-24
00083059070224Intact-PTH [Parathyroid Hormone] ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.CEW2020-07-01
00630414293745Atellica IM PTHSiemens Healthcare Diagnostics Inc.CEW2020-05-31
00380740156244ARCHITECTAbbott GmbHCEW2020-03-03
00850002253115Scantibodies Laboratory, Inc.SCANTIBODIES LABORATORY, INC.CEW2019-05-20
00850002253122Scantibodies Laboratory, Inc.SCANTIBODIES LABORATORY, INC.CEW2019-05-20
00850002253139Scantibodies Laboratory, Inc.SCANTIBODIES LABORATORY, INC.CEW2019-05-20
00840239036452PTH (Parathyroid) Intact ELISADRG International IncCEW2019-03-20
00630414592398ADVIA Centaur® PTHSiemens Healthcare Diagnostics Inc.CEW2018-11-12
00380740136215AlinityAbbott GmbHCEW2018-10-24
00630414592336ADVIA Centaur® PTHSiemens Healthcare Diagnostics Inc.CEW2018-08-21
00630414592343ADVIA Centaur® PTHSiemens Healthcare Diagnostics Inc.CEW2018-08-21
00630414592381ADVIA Centaur® PTHSiemens Healthcare Diagnostics Inc.CEW2018-08-21
00630414599441Atellica IM PTHSiemens Healthcare Diagnostics Inc.CEW2018-02-06
00630414599458Atellica IM PTHSiemens Healthcare Diagnostics Inc.CEW2018-02-06
B24221IPTHUE010PTH (Intact, 1-84) ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CEW2017-08-03
04015630939787Elecsys PTHRoche Diagnostics GmbHCEW2017-04-21