Solana

FDA UDI

Class I (US FDA UDI)

by Diagnostic Hybrids, Inc.

Identity

Trade Name: Solana FDA UDI
Generic Name: Influenza A/B virus nucleic acid IVD, control FDA UDI
Device Name: Solana Flu A+B Control Set FDA UDI
Model / Reference: M122 FDA UDI
Description: Solana Flu A+B Control Set FDA UDI

Identifiers

Catalog Number: M122 FDA UDI
Primary DI / UDI-DI: 30014613336990 FDA UDI
FDA Product Code: OHQ FDA UDI
GMDN Term: Influenza A/B virus 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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: Influenza A/B virus nucleic acid IVD, control

Solana by Diagnostic Hybrids, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Influenza A/B virus nucleic acid IVD, control.

cobas® Influenza A/B Quality Control Kit for use on the cobas® Liat® System — Roche Molecular Systems, Inc. · Class II
ID NOW Influenza A & B 2 Control Swab Kit — Alere Scarborough, Inc. · Class II
Quidel Molecular — DIAGNOSTIC HYBRIDS, INC. · Class I

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

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

Manufacturer

Manufacturer: Diagnostic Hybrids, Inc.

Sources (1)

FDA UDI 54ac5c84-c095-41a4-9844-6c3e4e8d4bc0 35 fields · synced May 30, 2026