Helix Elite™ Molecular Standards: Inactivated Standard

FDA UDI

Class I (US FDA UDI)

by Microbiologics, Inc.

Identity

Trade Name: Helix Elite™ Molecular Standards: Inactivated Standard FDA UDI
Generic Name: SARS-CoV-2 antigen IVD, control FDA UDI
Device Name: Helix Elite™ Molecular Standards SARS-CoV-2 Whole Virus Antigen Control (Swab) FDA UDI
Model / Reference: HE0068AG FDA UDI
Description: Helix Elite™ Molecular Standards SARS-CoV-2 Whole Virus Antigen Control (Swab) FDA UDI

Identifiers

Catalog Number: HE0068AG FDA UDI
Primary DI / UDI-DI: 10845357043754 FDA UDI
FDA Product Code: MJZ FDA UDI
GMDN Term: SARS-CoV-2 antigen IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: SARS-CoV-2 antigen IVD, control

Helix Elite™ Molecular Standards: Inactivated Standard by Microbiologics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Microbiologics, Inc.

Sources (1)

FDA UDI 6ab721ab-4c38-4eda-8f05-b08ac4f667c7 36 fields · synced May 30, 2026