Signify®

GUDID 10815845020062

ALERE SAN DIEGO, INC.

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical
Primary Device ID10815845020062
NIH Device Record Key658b227b-3dec-4886-803b-d376131f74ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameSignify®
Version Model Number01P52-25
Company DUNS194854949
Company NameALERE SAN DIEGO, INC.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Customer Support Contacts

Phone(866) 216-0094
Emailxx@xx.xx
Phone(866) 216-0094
Emailxx@xx.xx
Phone(866) 216-0094
Emailxx@xx.xx
Phone(866) 216-0094
Emailxx@xx.xx
Phone(866) 216-0094
Emailxx@xx.xx
Phone(866) 216-0094
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100815845020065 [Unit of Use]
GS110815845020062 [Primary]

FDA Product Code

KTNSystem, Test, Infectious Mononucleosis

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-06-10
Device Publish Date2016-09-24

On-Brand Devices [Signify®]

1081584502008601P48-25
1081584502006201P52-25
1081584502005501P46-50
1081584502007901P53-25

Trademark Results [Signify]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SIGNIFY
SIGNIFY
97825775 not registered Live/Pending
SIGNIFY WEALTH
2023-03-07
SIGNIFY
SIGNIFY
97745097 not registered Live/Pending
Tremor International Ltd.
2023-01-06
SIGNIFY
SIGNIFY
97526269 not registered Live/Pending
Wells Fargo & Company
2022-07-29
SIGNIFY
SIGNIFY
97324281 not registered Live/Pending
The Andersons, Inc.
2022-03-22
SIGNIFY
SIGNIFY
87848328 not registered Live/Pending
PHILIPS LIGHTING HOLDING B.V.
2018-03-24
SIGNIFY
SIGNIFY
87579270 not registered Dead/Abandoned
3M Company
2017-08-22
SIGNIFY
SIGNIFY
86679757 4895525 Live/Registered
Evolutionary Apparel Inc.
2015-06-30
SIGNIFY
SIGNIFY
86677227 5142544 Live/Registered
APDN (B.V.I.) Inc.
2015-06-29
SIGNIFY
SIGNIFY
86132348 not registered Dead/Abandoned
3M Company
2013-12-02
SIGNIFY
SIGNIFY
85674257 4621612 Live/Registered
Globus Medical, Inc
2012-07-11
SIGNIFY
SIGNIFY
85267492 4041546 Dead/Cancelled
Sigler Companies, Inc.
2011-03-15
SIGNIFY
SIGNIFY
79307335 not registered Live/Pending
Signify Holding B.V.
2021-01-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.