FDA.reportPublic FDA data

IGF-1 AccuBind ELISA Test System - 192 Wells

Primary DI
00816870024882
Brand
IGF-1 AccuBind ELISA Test System - 192 Wells
Company
MONOBIND, INC.
Model
13325-300
Catalog number
13325-300B
Published
2024-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00816870024882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816870024882008168700248828168700248820816870024882

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
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
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 Hormone (Recombinant 98/574)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24
00630414964041IMMULITE®/IMMULITE® 1000 Systems IG1 IGF-1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24
00630414964089IMMULITE/IMMULITE 1000 Systems Growth Hormone (Recombinant 98/574)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFL2020-09-24