FDA.reportPublic FDA data

DPP Zika IgM Micro Reader

Primary DI
00607158000113
Brand
DPP Zika IgM Micro Reader
Company
Chembio Diagnostic Systems Inc.
Model
70-1064-0
Catalog number
70-1064-0
Device description
The DPP® Micro Reader for use with the DPP Zika IgM Assay System is a reflectance reader configured to read exclusive results of the DPP Zika IgM test cartridge, through the application of an RFID tag applied to one side of the reader, which carries the DPP Zika test configuration. Once configured, the reader measures the intensity of the control and analyte lines on the test device, and shows the test results on the LCD display. The DPP Micro Reader minimizes human errors due to subjective visual interpretation; therefore, the operator cannot visually interpret the results of DPP Assay Devices made to be read with a DPP Micro Reader; they must be read exclusively with the DPP Micro Reader.
Published
2021-10-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JJQColorimeter, Photometer, Spectrophotometer For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJQColorimeter, Photometer, Spectrophotometer For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00607158000113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00607158000113006071580001136071580001130607158000113

GMDN Terms#

Term, Definition table
TermDefinition
Photometer, reflectanceAn instrument that measures the amount of light emitted by a light source, e.g., a light-emitting diode, as reflected from a sample in order to determine the concentration of an element. The device usually contains a photodiode for light detection.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
160348470
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08100322953854Procise IFX53852024-08-16
08100322954301Procise ADL54302024-08-16
08100322954295ProciseDx Calibration Cartridge54292024-08-06
08100322943909ProciseDx Analyzer43902024-08-05
00607158000083DPP HIV-Syphilis65-9502-02020-12-29
00607158000106DPP Zika IgM System65-9560-02020-08-06
00607158000007Chembio DPP HIV 1/2 Assay65-9500-02014-09-01
00607158000021Clearview Complete HIV 1/260-9523-02014-09-01
00607158000038Clearview HIV Reactive/Nonreactive Controls60-9546-02014-09-01
00607158000045Chembio DPP HIV 1/2 Rapid Test Control Pack60-9552-02014-09-01
00607158000052Chembio HIV 1/2 Stat-Pak Assay60-9505-12014-09-01
00607158000069Chembio SURE CHECK HIV 1/2 Assay60-9507-02016-06-01
00607158000076Chembio HIV Reactive/Nonreactive Controls60-9549-02014-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814905021479Safe Waste System Spectrophotometer for Pharmaceutical AnalysisCODONICS INC.JJQ2026-04-20
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00850049545501Diagnostic Automation, Inc.Diagnostic Automation, Inc.JJQ2025-12-24
00860011967750ZELLECHEM 200STERILE SAFEQUIP & CHEMICALS LLPJJQ2024-10-01
00816467020396FastPack® IP SystemQUALIGEN INC.JJQ2024-09-27
00816467020402FastPack® IP SystemQUALIGEN INC.JJQ2024-09-27
00816870020006NeoLumax CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020013LuMatic CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020051NeoEldex ELISA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020068PrisMatic ELISA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020075Autoplex G1 ELISA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020082Autoplex G2 ELISA + CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870024448Autoplex G3 ELISA + CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
07290016923063Auto Sampler (for BreathID Hp Lab System)MERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
07290016923384BreathID Hp Lab DeviceMERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
07290016923391BreathID Hp Lab Device (WIN)MERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
00860011967743ZELLECHEM-PROSTERILE SAFEQUIP & CHEMICALS LLPJJQ2024-07-09
04048474052527DRG:HYBRiD.XL®DRG Instruments Gesellschaft mit beschränkter HaftungJJQ2023-09-02
00840239052520DRG:HYBRiD.XL®DRG International IncJJQ2023-08-26
10810138822705EndocatorEndo Direct LLCJJQ2023-07-16
09120052071184SUNRISETecan Austria GmbHJJQ2023-07-06
09120052071191SUNRISE-RC/ST EVOLYZERTecan Austria GmbHJJQ2023-07-06
09120052071207SUNRISE-RC/TW EVOLYZERTecan Austria GmbHJJQ2023-07-06
09120052071214SUNRISE-RC/6F EVOLYZERTecan Austria GmbHJJQ2023-07-06
06936895300151BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
06936895300212BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
06936895300229BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
06936895300236BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
06936895300243BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
00850229007010StatFaxAWARENESS TECHNOLOGY, INCORPORATEDJJQ2023-06-05