FDA.reportPublic FDA data

SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 192 Wells

Primary DI
00816870024875
Brand
SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 192 Wells
Company
MONOBIND, INC.
Model
12525-300
Catalog number
12525-300B
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
QKOReagent, coronavirus serological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKOReagent, Coronavirus SerologicalUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816870024875PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816870024875008168700248758168700248750816870024875

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 immunoglobulin G (IgG) antibody 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 immunoglobulin G (IgG) antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using an enzyme immunoassay (EIA) method. This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.

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
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00816870023595SARS-CoV-2 IgG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.QKO2024-09-13
00816870023601SARS-CoV-2 IgG AccuBind ELISA Test System - 192 WellsMONOBIND, INC.QKO2024-09-13
00816870023632SARS-CoV-2 IgM AccuBind ELISA Test System - 96 WellsMONOBIND, INC.QKO2024-09-13
00816870023649SARS-CoV-2 IgM AccuBind ELISA Test System - 192 WellsMONOBIND, INC.QKO2024-09-13
00816870024868SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.QKO2024-09-13
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