Solana M308

GUDID 30014613336167

Solana Bordetella Complete

DIAGNOSTIC HYBRIDS, INC.

Multiple Bordetella species nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID30014613336167
NIH Device Record Key9a928115-59b8-4552-87e6-08923aaaba4f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSolana
Version Model NumberM308
Catalog NumberM308
Company DUNS117359612
Company NameDIAGNOSTIC HYBRIDS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com
Phone+1(858)552-1100
Emailtechnicalsupport@quidel.com

Device Identifiers

Device Issuing AgencyDevice ID
GS130014613336167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OZZBordetella pertussis dna assay system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-12
Device Publish Date2020-02-04

On-Brand Devices [Solana]

30014613336440Solana GBS Assay
30014613337003Solana RSV+hMPV Control Set
30014613336990Solana Flu A+B Control Set
30014613336983Solana HSV 1+2/ VZV Control set
30014613336150Solana C. difficile Assay
30014613336143Solana RSV/hMPB Assay
30014613336136Solana Strep A/C & G Assay
30014613336105Solana HSV 1+2/ VZV Assay
30014613336068Solana Infulenza A+B Assay
30014613336167Solana Bordetella Complete

Trademark Results [Solana]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOLANA
SOLANA
98363332 not registered Live/Pending
Kai Corporation
2024-01-18
SOLANA
SOLANA
97880364 not registered Live/Pending
Advanced Inventory Management, Inc.
2023-04-10
SOLANA
SOLANA
97824489 not registered Live/Pending
Solana Auto Group LLC
2023-03-06
SOLANA
SOLANA
97773543 not registered Live/Pending
Solano Nutrition LLC
2023-01-30
SOLANA
SOLANA
97344226 not registered Live/Pending
101412 LLC
2022-04-02
SOLANA
SOLANA
90695759 not registered Live/Pending
Solana Foundation
2021-05-07
SOLANA
SOLANA
90218223 not registered Live/Pending
Diono, LLC
2020-09-28
SOLANA
SOLANA
88847695 not registered Live/Pending
97th Floor
2020-03-25
SOLANA
SOLANA
88371786 not registered Live/Pending
Bulbrite Industries, Inc.
2019-04-04
SOLANA
SOLANA
86813444 not registered Dead/Abandoned
Dümmen Group B.V.
2015-11-09
SOLANA
SOLANA
86507158 4974172 Live/Registered
Horizon Software International, LLC
2015-01-19
SOLANA
SOLANA
86298951 4814038 Live/Registered
Quidel Corporation
2014-06-03

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