← Back to catalogue

DPP Zika IgM System

FDA UDI

Class II (US FDA UDI)

by Chembio Diagnostic Systems

Identity

Trade Name
DPP Zika IgM System FDA UDI
Generic Name
Zika virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The DPP Zika IgM System is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human serum (plain or separation gel), potassium-EDTA plasma, potassium EDTA venous whole blood, or fingerstick whole blood specimens, collected from individuals meeting the CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). FDA UDI
Model / Reference
65-9560-0 FDA UDI
Description
The DPP Zika IgM System is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human serum (plain or separation gel), potassium-EDTA plasma, potassium EDTA venous whole blood, or fingerstick whole blood specimens, collected from individuals meeting the CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). FDA UDI

Identifiers

Primary DI / UDI-DI
00607158000106 FDA UDI
510(k) Number
K200506 FDA UDI
FDA Product Code
QFO FDA UDI
GMDN Term
Zika virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3935 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Zika virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

DPP Zika IgM System by Chembio Diagnostic Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Zika virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Chembio Diagnostic Systems

Sources (1)

  • FDA UDI b1324d01-543c-4023-8282-9e1124172e4c 34 fields · synced May 30, 2026