FDA.reportPublic FDA data

hGH AccuLite CLIA Test System - 192 Wells

Primary DI
00816870022710
Brand
hGH AccuLite CLIA Test System - 192 Wells
Company
MONOBIND, INC.
Model
1775-300B
Catalog number
1775-300B
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
CFLRADIOIMMUNOASSAY, HUMAN GROWTH HORMONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFLRadioimmunoassay, Human Growth HormoneClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816870022710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816870022710008168700227108168700227100816870022710

GMDN Terms#

Term, Definition table
TermDefinition
Growth hormone releasing hormone (GHRH) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of growth hormone releasing hormone (GHRH) 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
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
00850049545815AccuDiag™ Human Growth Hormone (HGH) ELISADiagnostic Automation, Inc.CFL2026-01-27
B24211HGHHUE010Human Growth Hormone ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFL2025-01-20
04048474018646TGF-Beta 1 ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFL2024-11-22
04048474023961TGF-Beta 2 ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFL2024-11-22
00816870024813IGF-1 AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CFL2024-09-13
00816870024820IGF-1 AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CFL2024-09-13
00816870024882IGF-1 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CFL2024-09-13
00816870024899IGF-1 AccuLite CLIA Test System - 192 WellsMONOBIND, INC.CFL2024-09-13
04048474041408IGF-1 600 ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFL2023-08-31
04048474017878Human Growth Hormone (HGH) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFL2023-08-26
00840239041401IGF-1 600 ELISADRG International IncCFL2023-08-25
00840239035523HGH (Human Growth Hormone) ELISADRG International IncCFL2023-08-24
00840239018649TGF-B1 ELISADRG International IncCFL2023-08-23
00840239023964TGF-B2 ELISADRG International IncCFL2023-08-23
B261CANGH40700DBC Growth Hormone (GH) ELISADiagnostics Biochem Canada IncCFL2022-11-15
06925912719281iFlash-hGHShenzhen YHLO Biotech Co., Ltd.CFL2022-10-26
03770024321562HGH-USCISBIO BIOASSAYSCFL2021-12-07
00404847441406IGF-1 600 ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFL2021-06-11
00840239017871Human Growth Hormone (HGH) ELISADRG International IncCFL2021-06-09
00404847418644TGF-Beta 1 ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFL2021-06-07
00404847423969TGF-Beta 2 ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFL2021-06-07
04015630926664Elecsys hGHRoche Diagnostics GmbHCFL2021-01-18
00630414601236IMMULITE® 2000 Systems IGF-ISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24
00630414601243IMMULITE®/IMMULITE® 1000 Systems IGF-ISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24
00630414953212IMMULITE® Systems IG1 CONTROL IGF-1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24
00630414953809IMMULITE®/IMMULITE® 1000 Systems GH Growth Hormone Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24
00630414953922IMMULITE® 2000 Systems IG1 IGF-I Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24
00630414961538IMMULITE® 2000 Systems IGF-1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24
00630414961552IMMULITE 2000 Systems Growth HormoneSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24
00630414964041IMMULITE®/IMMULITE® 1000 Systems IG1 IGF-1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24