PRODESSE 303111

GUDID 15420045506329

Hologic, Inc.

Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID15420045506329
NIH Device Record Key5e3ff968-17e8-46f1-952a-fee46ed32918
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRODESSE
Version Model NumberPRODESSE PROFLU+ ASSAY
Catalog Number303111
Company DUNS050579217
Company NameHologic, Inc.
Device Count1
DM Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045506329 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OCCRespiratory virus panel nucleic acid assay system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-04-15

On-Brand Devices [PRODESSE]

15420045506398PROPARAFLU+ KIT, 100 REACTIONS
15420045506381PROADENO+ KIT, 100 REACTIONS
15420045506374PROFAST+ KIT, 100 REACTIONS
15420045506367PRO HMPV+ KIT, 100 REACTIONS
15420045506350PROGASTRO SSCS ASSAY
15420045506343PROFLU+ ASSAY KIT, 1,500 REACTIONS
15420045506336PROFLU+ ASSAY KIT, 2,000 REACTIONS
15420045506329PRODESSE PROFLU+ ASSAY

Trademark Results [PRODESSE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PRODESSE
PRODESSE
76476900 2868510 Dead/Cancelled
GEN-PROBE PRODESSE, INC.
2002-12-19

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