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Helix Elite Molecular Standards

FDA UDI

Class I (US FDA UDI)

by Microbiologics, Inc.

Identity

Trade Name
Helix Elite Molecular Standards FDA UDI
Generic Name
Multiple-type gastrointestinal pathogen nucleic acid IVD, control FDA UDI
Model / Reference
GS-0001 FDA UDI

Identifiers

Primary DI / UDI-DI
80845357044422 FDA UDI
FDA Product Code
OHQ FDA UDI
GMDN Term
Multiple-type gastrointestinal pathogen nucleic acid 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

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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

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 gastrointestinal pathogen nucleic acid IVD, control

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

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Microbiologics, Inc.

Sources (1)

  • FDA UDI df55783a-7daf-4c48-957a-f779c1298be5 33 fields · synced May 30, 2026