FDA.reportPublic FDA data

sTfR AccuLite CLIA Test System - 192 Wells

Primary DI
00816870020341
Brand
sTfR AccuLite CLIA Test System - 192 Wells
Company
MONOBIND, INC.
Model
8675-300
Catalog number
8675-300B
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
DDGTRANSFERRIN, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816870020341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816870020341008168700203418168700203410816870020341

GMDN Terms#

Term, Definition table
TermDefinition
Transferrin IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of transferrin in a clinical specimen, using a chemiluminescent immunoassay 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
Premarket exempt
true
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

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Primary DI, Brand, Company table
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04015630919444sTfR Control SetRoche Diagnostics GmbHDDG2021-02-08
00380740161439ARCHITECTAbbott GmbHDDG2020-11-06
00380740161446ARCHITECTAbbott GmbHDDG2020-11-06
07613336147924Tina-quant Soluble Transferrin ReceptorRoche Diagnostics GmbHDDG2020-10-29
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00380740135096AlinityAbbott GmbHDDG2019-06-27
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00842768008054N Latex sTfRSiemens Healthcare Diagnostics Products GmbHDDG2016-09-24
00842768008061N Supplementary Reagent LSiemens Healthcare Diagnostics Products GmbHDDG2016-09-24
00842768009891N Antiserum to Human TransferrinSiemens Healthcare Diagnostics Products GmbHDDG2016-09-24
00842768009907N Antiserum to Human TransferrinSiemens Healthcare Diagnostics Products GmbHDDG2016-09-24
04015630914395Tinaquant Soluble Transferrin ReceptorRoche Diagnostics GmbHDDG2016-09-20
04015630917419Tinaquant Transferrin ver2Roche Diagnostics GmbHDDG2016-09-20
04015630917426Transferrin ver 2 Tinaquant Transferrin ver2Roche Diagnostics GmbHDDG2016-09-20
04015630917440Transferrin ver 2 Tinaquant Transferrin ver2Roche Diagnostics GmbHDDG2016-09-20
04015630918614Tinaquant Soluble Transferrin ReceptorRoche Diagnostics GmbHDDG2016-09-20