FDA.reportPublic FDA data

N-17-OHP AccuBind ELISA Test System - 1920 Wells

Primary DI
00816870021201
Brand
N-17-OHP AccuBind ELISA Test System - 1920 Wells
Company
MONOBIND, INC.
Model
5525-300
Catalog number
5525-300F
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
JLXRADIOIMMUNOASSAY, 17-HYDROXYPROGESTERONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JLXRadioimmunoassay, 17-HydroxyprogesteroneClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816870021201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816870021201008168700212018168700212010816870021201

GMDN Terms#

Term, Definition table
TermDefinition
17-Hydroxyprogesterone 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 17-hydroxyprogesterone in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis of congenital adrenal hyperplasia (CAH).

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
00816870021294903 DBS Collection Cards - 6 Samples329MM329MM2024-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B261CANP5400DBC 17α-Hydroxyprogesterone (17α-OHP) ELISADiagnostics Biochem Canada IncJLX2026-04-27
00894175000770AccuDiag™ 17-alpha-OH Progesterone ELISADiagnostic Automation, Inc.JLX2026-01-27
0404847401292717 OH-Progesterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLX2024-11-18
00816870021164N-17-OHP AccuBind ELISA Test System - 96 WellsMONOBIND, INC.JLX2024-09-13
00816870021171N-17-OHP AccuBind ELISA Test System - 192 WellsMONOBIND, INC.JLX2024-09-13
00816870021188N-17-OHP AccuBind ELISA Test System - 480 WellsMONOBIND, INC.JLX2024-09-13
00816870021195N-17-OHP AccuBind ELISA Test System - 960 WellsMONOBIND, INC.JLX2024-09-13
04048474031409Salivary 17-OH Progesterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLX2023-09-01
04048474053333Progesterone (17-a-OH Progesterone)DRG Instruments Gesellschaft mit beschränkter HaftungJLX2023-09-01
00840239031402Salivary 17-OH Progesterone ELISADRG International IncJLX2023-08-26
00840239053336Progesterone (17-a-OH Progesterone)DRG International IncJLX2023-08-26
04048474014297Progesterone, 17 a-Hydroxy- (Neonate) (MW) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLX2023-08-26
0084023901292017 OH Progesterone ELISADRG International IncJLX2023-08-23
00840239012937C-Peptide ELISADRG International IncJLX2023-08-23
00840239014290Progesterone, 17 a-Hydroxy- (Neonate) (MW) ELISADRG International IncJLX2023-08-23
00840239046659Progesterone, 17-a-OHDRG International IncJLX2023-08-22
00817830023150MP Biomedicals LLCMp Biomedicals, LLCJLX2023-08-02
0404932503362717-OH-Progesterone ELISAIBL International GmbHJLX2022-12-28
0404901613838917-OH Progesterone ELISAEUROIMMUN Medizinische Labordiagnostika AGJLX2022-12-08
B261CANP3200DBC 17α-Hydroxyprogesterone (17α-OHP) ELISADiagnostics Biochem Canada IncJLX2022-11-15
B261CANP4000DBC 17α-Hydroxyprogesterone (17α-OHP) ELISADiagnostics Biochem Canada IncJLX2022-11-15
06925912718048iFlash-17α-OH-PShenzhen YHLO Biotech Co., Ltd.JLX2022-10-26
0040484741292517 OH-Progesterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLX2021-06-07
00404847431407Salivary 17-OH Progesterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLX2021-06-07
00404847446654Progesterone, 17-a-OH ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLX2021-06-07
00404847453331Progesterone (17-a-OH Progesterone)DRG Instruments Gesellschaft mit beschränkter HaftungJLX2021-06-07
00725609000625SPOTCHECKASTORIA-PACIFIC, INC.JLX2020-12-17
B2422017OHUE01017-alpha Hydroxy Progesterone ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JLX2020-06-18
B2422017OHUE01SLV017-alpha Hydroxy Progesterone ELISA (Saliva)AMERICAN LABORATORY PRODUCTS COMPANY, LTD.JLX2020-06-18
0540056900047617OHP RIA CTDiasource Immunoassays S.A. SAJLX2020-01-15