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QC Sets and Panels: Helix Elite™

FDA UDIEUDAMED

Class II (US FDA UDI)

by Microbiologics, Inc.

Identity

Trade Name
QC Sets and Panels: Helix Elite™ FDA UDI
Generic Name
Multiple-type sexually transmitted pathogen nucleic acid IVD, control FDA UDI
Device Name
Assayed CT/NG Control Panel FDA UDI
Model / Reference
8188 Cepheid Xpert® CT/NG Control Panel FDA UDI
Description
Assayed CT/NG Control Panel FDA UDI

Identifiers

Catalog Number
8188 FDA UDI
Primary DI / UDI-DI
70845357041189 FDA UDI
510(k) Number
K190223 FDA UDI
FDA Product Code
PMN FDA UDI
GMDN Term
Multiple-type sexually transmitted pathogen nucleic acid IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3920 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

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple-type sexually transmitted pathogen nucleic acid IVD, control

QC Sets and Panels: Helix Elite™ by Microbiologics, Inc. — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-type sexually transmitted pathogen nucleic acid IVD, control.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Microbiologics, Inc.

Sources (2)

  • FDA UDI 7d2e6f90-bf33-4ac5-a034-62c316885719 37 fields · synced Jun 20, 2026
  • EUDAMED 1 fields · synced Jun 1, 2026