FDA.reportPublic FDA data

Monobind AccuLite Progesterone CLIA Kit - 192 Wells

Primary DI
00816870022864
Brand
Monobind AccuLite Progesterone CLIA Kit - 192 Wells
Company
MONOBIND, INC.
Model
4875-300
Catalog number
4875-300B
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
JLSRADIOIMMUNOASSAY, PROGESTERONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JLSRadioimmunoassay, ProgesteroneClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816870022864PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816870022864008168700228648168700228640816870022864

GMDN Terms#

Term, Definition table
TermDefinition
Progesterone IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of progesterone 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
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
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
00894175000800AccuDiag™ Progesterone ELISADiagnostic Automation, Inc.JLS2026-01-30
24562185399664CL AIA-PACK Progesterone TEST CUPTOSOH CORPORATIONJLS2025-09-01
20758750035363VITROSORTHO CLINICAL DIAGNOSTICSJLS2025-05-20
04048474015614Progesterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLS2024-11-22
04048474046632Progesterone (serum) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLS2024-11-21
07613336218419Elecsys Progesterone IIIRoche Diagnostics GmbHJLS2024-05-30
15099590752682Access Progesterone IIBeckman Coulter, Inc.JLS2024-03-01
15099590752705Access Progesterone II Sample DiluentBeckman Coulter, Inc.JLS2024-03-01
04048474029314Salivary Progesterone ELISA DRG Instruments Gesellschaft mit beschränkter HaftungJLS2023-09-01
04048474053685Progesterone DRG Instruments Gesellschaft mit beschränkter HaftungJLS2023-09-01
04048474059113Salivary Progesterone HS ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLS2023-09-01
00840239029317Salivary Progesterone ELISA DRG International IncJLS2023-08-26
00840239053688Progesterone DRG International IncJLS2023-08-26
00840239059116Salivary Progesterone HS ELISADRG International IncJLS2023-08-26
00840239015617Progesterone ELISADRG International IncJLS2023-08-23
00840239046635Progesterone (serum) DRG International IncJLS2023-08-22
00817830023167MP Biomedicals LLCMp Biomedicals, LLCJLS2023-08-02
00817830023174MP Biomedicals LLCMp Biomedicals, LLCJLS2023-08-02
00817830023181MP Biomedicals LLCMp Biomedicals, LLCJLS2023-08-02
00817830023198MP Biomedicals LLCMp Biomedicals, LLCJLS2023-08-02
00850039602733PantexPantexJLS2023-03-17
00850039602375PantexPantexJLS2023-02-17
B261CANP3050DBC Progesterone ELISADiagnostics Biochem Canada IncJLS2022-11-15
06925912718918iFlash-ProgesteroneShenzhen YHLO Biotech Co., Ltd.JLS2022-10-26
03770024321609PROGEST-USCISBIO BIOASSAYSJLS2021-12-07
15099590231354ACCESS PROGESTERONE CALIBRATOR S0Beckman Coulter, Inc.JLS2021-09-03
15099590231378Access ProgesteroneBeckman Coulter, Inc.JLS2021-09-03
00404847415612Progesterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLS2021-06-07
00404847429312Salivary Progesterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLS2021-06-07
00404847441574SALI-TUBES 500DRG Instruments Gesellschaft mit beschränkter HaftungJLS2021-06-07