DPP Zika IgM Micro Reader 70-1064-0

GUDID 00607158000113

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.

Chembio Diagnostic Systems Inc.

Photometer, reflectance

• Primary Device ID: 00607158000113
• NIH Device Record Key: 2203a34b-2d14-4267-9094-4a7ebfa6584b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DPP Zika IgM Micro Reader
• Version Model Number: 70-1064-0
• Catalog Number: 70-1064-0
• Company DUNS: 160348470
• Company Name: Chembio Diagnostic Systems Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607158000113 [Primary]

FDA Product Code

• JJQ: Colorimeter, Photometer, Spectrophotometer For Clinical Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-27
• Device Publish Date: 2021-10-19

Devices Manufactured by Chembio Diagnostic Systems Inc.

• 00607158000113 - DPP Zika IgM Micro Reader: 2021-10-27The 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.
• 00607158000113 - DPP Zika IgM Micro Reader: 2021-10-27 The DPP® Micro Reader for use with the DPP Zika IgM Assay System is a reflectance reader configured to read exclusive results o
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• 00607158000106 - DPP Zika IgM System: 2020-08-14 The DPP Zika IgM System is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human serum (plain
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