FDA.reportPublic FDA data

Anti-Tg AccuBind ELISA Test System - 96 Wells

Primary DI
00816870020389
Brand
Anti-Tg AccuBind ELISA Test System - 96 Wells
Company
MONOBIND, INC.
Model
1025-300
Catalog number
1025-300A
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
DDCTHYROGLOBULIN, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DDCThyroglobulin, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971835000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971835000ANTI-THYROGLOBULIN (TG) MICROPLATE ELISAMonobind1997-07-03DDC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816870020389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816870020389008168700203898168700203890816870020389

GMDN Terms#

Term, Definition table
TermDefinition
Thyroglobulin 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 antibodies to thyroglobulin 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
Special Storage Condition, Specify00Handling Environment Temperature
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
04048474041101Anti-Thyroglobulin (Anti-Tg) ELISADRG Instruments Gesellschaft mit beschränkter HaftungDDC2023-08-31
04048474027914TPO IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungDDC2023-08-29
00840239027894Cardiolipin IgM ELISADRG International IncDDC2023-08-24
00840239027917TPO IgG ELISADRG International IncDDC2023-08-24
00840239041104Anti-Thyroglobulin (Anti-Tg) ELISADRG International IncDDC2019-03-20
00816870022062Anti-Tg AccuLite CLIA Test System - 96 WellsMONOBIND, INC.DDC2019-02-11
05056080500027NAREMEL EUROPE LIMITEDDDC2016-12-09
05056080500034NAREMEL EUROPE LIMITEDDDC2016-12-09
00816879020038Autostat II Anti-ThyroglobulinHYCOR BIOMEDICAL LLCDDC2016-09-26
08426950454465QUANTA Lite® Thyroid T ELISAINOVA DIAGNOSTICS, INC.DDC2016-08-31
00850487007241ReQuest QUEST INTERNATIONAL, INC.DDC2016-08-31
00850487007494SeraQuestQUEST INTERNATIONAL, INC.DDC2016-08-31