FDA.reportPublic FDA data

Immunoassay Plate Washer

Primary DI
00816870020044
Brand
Immunoassay Plate Washer
Company
MONOBIND, INC.
Model
IN002
Catalog number
IN002
Published
2024-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816870020044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816870020044008168700200448168700200440816870020044

GMDN Terms#

Term, Definition table
TermDefinition
Microplate washer IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for washing microplates containing multiple individual sample wells (i.e., the removal of biological specimen residue, stains, or impurities) by dispensing and aspirating measured volumes of washing solution as part of the processing required to perform an in vitro diagnostic assay.

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
Serial number
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435389828150SAMPLE PREPARATION KITBIOTECHNOLOGY INSTITUTE SLLXG2026-05-27
00816394021855Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021930Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021947Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021954Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021985Helmer ScientificHELMER, INC.LXG2026-05-13
00816394021992Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022005Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022012Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022050Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022067Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022074Helmer ScientificHELMER, INC.LXG2026-05-13
00816394022081Helmer ScientificHELMER, INC.LXG2026-05-13
15099590695743iChemVELOCITYBECKMAN COULTER IRELAND INC.LXG2026-04-27
09120123910022Anchor Tips, 300uLSTRATEC Consumables GmbHLXG2026-01-14
26974573531033CellproSuzhou CellPro Biotechnology Co., Ltd.LXG2025-11-21
10818207025071Endocator Starter KitVista DentalLXG2025-11-07
10818207025088Endocator Swabs (20pk)Vista DentalLXG2025-11-07
00810100050269KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050283KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050306KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050511KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050528KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050535KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050542KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050559KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050603KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100050610KBMEDKB Medical (group), Inc.LXG2025-05-22
00810100051297KBMEDKB Medical (group), Inc.LXG2025-05-22
20885380197861CARDINAL HEALTHCardinal Health 200, LLCLXG2025-04-18