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: PCR/NAT negative control IVD FDA UDI
Device Name: Helix Elite™ Molecular Standards Inactivated Negative Blank Control FDA UDI
Model / Reference: HE0081NS FDA UDI
Description: Helix Elite™ Molecular Standards Inactivated Negative Blank Control FDA UDI

Identifiers

Catalog Number: HE0081NS FDA UDI
Primary DI / UDI-DI: 10845357044324 FDA UDI
FDA Product Code: OHQ FDA UDI
GMDN Term: PCR/NAT negative control IVD 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: PCR/NAT negative control IVD

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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Exact Diagnostics — Exact Diagnostics · Class I
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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 da2f6303-a420-4583-a068-8934255c96a7 36 fields · synced May 29, 2026