RealTime 6L18-80

GUDID 00884999023932

Abbott RealTime HIV-1 Control Kit

ABBOTT MOLECULAR INC.

HIV1 nucleic acid IVD, control
Primary Device ID00884999023932
NIH Device Record Keyffc1fbef-e794-46ab-ade5-ed6de9d3fd32
Commercial Distribution StatusIn Commercial Distribution
Brand NameRealTime
Version Model Number6L18-80
Catalog Number6L18-80
Company DUNS878263359
Company NameABBOTT MOLECULAR 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(800)553-7042
Emailcustomerservice@abbottmolecular.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 and -10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100884999023932 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-26
Device Publish Date2016-07-01

On-Brand Devices [RealTime]

00884999048065Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM
00884999047792Abbott RealTime IDH1m2000rt Application CD-ROM
00884999047358Abbott RealTime IDH1 Amplification Reagent Kit
00884999047341Abbott RealTime IDH1 Control Kit
00884999047297Abbott RealTime CMV m2000 System Combined Application CD-ROM
00884999047051Abbott RealTime IDH2 Control Kit
00884999047044Abbott RealTime IDH2 Amplification Reagent Kit
00884999047037Abbott RealTime IDH2 m2000rt Application CD-ROM
00884999046603Abbott Proteinase K Recombinant, PCR Grade
00884999045798Abbott RealTime CMV Amplification Reagent Kit
00884999045781Abbott RealTime CMV Control Kit
00884999045774Abbott RealTime CMV Calibrator Kit
00884999042704Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM
00884999042681Abbott RealTime HCV m2000 System Combined Application CD-ROM
00884999042667Abbott RealTime HBV m2000 System Combined Application CD-ROM
00884999042513Abbott RealTime HCV Genotype II m2000 System Combined Application CD-ROM
00884999038462Abbott RealTime HBV Amplification Reagent Kit
00884999037762Abbott RealTime HBV m2000 System Combined Application CD-ROM, Version 3.0
00884999037656Abbott RealTime HCV m2000 System Combined Application CD-ROM, Version 3.0
00884999037472Uracil-N-Glycosylase (UNG)
00884999037434Abbott RealTime HCV Including Uracil-N-Glycosylase (UNG)
00884999037427Abbott RealTime HIV-1 Amplification Extended Use Including Uracil-N-Glycosylase (UNG)
00884999037410Abbott RealTime CT/NG Amplification Reagent Extended Use Including Uracil-N-Glycosylase (UNG)
00884999037304Abbott RealTime HIV-1 Amplification Reagent Extended Use
00884999037298Abbott RealTime CT/NG Amplification Reagent Extended Use with Pierceable Caps
00884999037168Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM, Version 6.0
00884999037113Abbott m2000 System Chlamydia trachomatis and Neisseria gonorrhoeae Application CD-ROM, Version
00884999036444Uracil-N-Glycosylase (UNG) for use in conjunction with Abbott RealTime HCV Genotype II Assay
00884999036147Abbott RealTime HCV Genotype II Control Kit
00884999036130Abbott RealTime HCV Genotype II Amplification Reagent Kit
00884999034266Abbott RealTime HCV Genotype II m2000 System Combined Application CD-ROM, Version 1.0
00884999031142Abbott RealTime CT/NG Amplification Reagent Kit
00884999031128Abbott RealTime CT/NG Control Kit
00884999023949Abbott RealTime HIV-1 Amplification Reagent Kit
00884999023932Abbott RealTime HIV-1 Control Kit
00884999023925Abbott RealTime HIV-1 Calibrator Kit
00884999023918Abbott RealTime HIV-1 Amplification Including Uracil-N-Glycosylase (UNG) for use in conjunction
00884999006584AM Transport Cap Standard
00884999003071Abbott RealTime HBV Amplification Reagent Kit
00884999003064Abbott RealTime HBV Control Kit
00884999003057Abbott RealTime HBV Calibrator Kit
00884999000728Abbott RealTime HCV Amplification Reagent Kit
00884999000711Abbott RealTime HCV Control Kit
00884999000704Abbott RealTime HCV Calibrator Kit
00884999000698Uracil-N-Glycosylase (UNG) for use in conjunction with Abbott RealTime HCV (List Number 1N30-90)
00884999049109Abbott RealTime SARS-CoV-2 Amplification Reagent Kit
00884999049086Abbott RealTime SARS-CoV-2 Control Kit
00884999049055Abbott RealTime SARS-CoV-2 Application CD-ROM
30884999049131Abbott Universal Collection Kit
00884999047068Abbott RealTime ZIKA Application CD-ROM

Trademark Results [RealTime]

Mark Image

Registration | Serial
Company
Trademark
Application Date
REALTIME
REALTIME
97314652 not registered Live/Pending
Sermo, Inc.
2022-03-16
REALTIME
REALTIME
90353636 not registered Live/Pending
MAGN TRADING INC
2020-12-02
REALTIME
REALTIME
87242159 not registered Live/Pending
Realtime R&L, Inc.
2016-11-18
REALTIME
REALTIME
86963065 not registered Dead/Abandoned
Machine Zone, Inc.
2016-04-04
REALTIME
REALTIME
86160626 4616538 Live/Registered
Realtime Information Technology, Inc.
2014-01-08
REALTIME
REALTIME
78788625 not registered Dead/Abandoned
Realtime R&L, Inc.
2006-01-10
REALTIME
REALTIME
78788621 3171541 Live/Registered
Realtime R&L, Inc.
2006-01-10
REALTIME
REALTIME
78718908 not registered Dead/Abandoned
Cooley Jr., Donald Ray
2005-09-22
REALTIME
REALTIME
78718908 not registered Dead/Abandoned
Anton, Dhryl
2005-09-22
REALTIME
REALTIME
78689252 3228827 Live/Registered
MSM Group, Inc.
2005-08-10
REALTIME
REALTIME
78383724 not registered Dead/Abandoned
Skyline Connections, Inc.
2004-03-12
REALTIME
REALTIME
78077932 not registered Dead/Abandoned
CD REWARDS INC.
2001-08-07

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