Determine™ HIV–1/2 Ag/Ab Combo

GUDID 00811877011101

Determine™ HIV–1/2 Ag/Ab Combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of HIV-1 p24 antigen (Ag) and antibodies (Ab) to HIV-1 and HIV-2 in human serum, plasma, capillary (fingerstick) whole blood or venipuncture (venous) whole blood.

Alere Scarborough, Inc.

HIV1/HIV2 antigen/antibody IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00811877011101
NIH Device Record Keyded26c83-d562-4cda-bb38-d4302441a19d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDetermine™ HIV–1/2 Ag/Ab Combo
Version Model Number7D2648
Company DUNS154148498
Company NameAlere Scarborough, 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100811877011101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MZFTest, Hiv Detection

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-21
Device Publish Date2022-01-13

Devices Manufactured by Alere Scarborough, Inc.

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00811877011477 - BinaxNOW COVID-19 Antigen Self Test2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
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Trademark Results [Determine]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DETERMINE
DETERMINE
87261003 not registered Live/Pending
Dover Artificial Lift Systems, LLC
2016-12-07
DETERMINE
DETERMINE
86714473 5177204 Live/Registered
DETERMINE INC.
2015-08-04
DETERMINE
DETERMINE
85243867 4214753 Dead/Cancelled
Makhteshim Agan of North America, Inc.
2011-02-16
DETERMINE
DETERMINE
78155051 not registered Dead/Abandoned
DETERMINE SOFTWARE, INC.
2002-08-16
DETERMINE
DETERMINE
77655561 4525985 Live/Registered
ALERE SWITZERLAND GMBH
2009-01-23
DETERMINE
DETERMINE
77654543 not registered Dead/Abandoned
Selectica, Inc.
2009-01-22
DETERMINE
DETERMINE
77125816 not registered Dead/Abandoned
Bristol-Myers Squibb Company
2007-03-08

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