FDA.reportPublic FDA data

IGF-1 AccuLite CLIA Test System - 96 Wells

Primary DI
00816870024820
Brand
IGF-1 AccuLite CLIA Test System - 96 Wells
Company
MONOBIND, INC.
Model
13375-300
Catalog number
13375-300A
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
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
00816870024820PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816870024820008168700248208168700248200816870024820

GMDN Terms#

Term, Definition table
TermDefinition
Insulin-like growth factor I (IGF1) 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 insulin-like growth factor I (IGF1), also referred to as somatomedin C, 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
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
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
00630414964089IMMULITE/IMMULITE 1000 Systems Growth HormoneSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24