Alinity 06S6101

GUDID 00380740193805

AdviseDx SARS-CoV-2 IgG II Calibrator Kit

Abbott Ireland Diagnostics

SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
Primary Device ID00380740193805
NIH Device Record Keye8e9b7cb-9802-4021-ac13-b17fbc904ced
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlinity
Version Model Number06S6101
Catalog Number06S6101
Company DUNS985307301
Company NameAbbott Ireland Diagnostics
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
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(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store below -20 CEL until first use
Handling Environment TemperatureBetween 0 and 0 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store below -20 CEL until first use
Handling Environment TemperatureBetween 0 and 0 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store below -20 CEL until first use
Handling Environment TemperatureBetween 0 and 0 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store below -20 CEL until first use
Handling Environment TemperatureBetween 0 and 0 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store below -20 CEL until first use
Handling Environment TemperatureBetween 0 and 0 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store below -20 CEL until first use
Handling Environment TemperatureBetween 0 and 0 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store below -20 CEL until first use
Handling Environment TemperatureBetween 0 and 0 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store below -20 CEL until first use
Handling Environment TemperatureBetween 0 and 0 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store below -20 CEL until first use
Handling Environment TemperatureBetween 0 and 0 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store below -20 CEL until first use
Handling Environment TemperatureBetween 0 and 0 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store below -20 CEL until first use
Handling Environment TemperatureBetween 0 and 0 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store below -20 CEL until first use
Handling Environment TemperatureBetween 0 and 0 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store below -20 CEL until first use
Handling Environment TemperatureBetween 0 and 0 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store below -20 CEL until first use
Handling Environment TemperatureBetween 0 and 0 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store below -20 CEL until first use
Handling Environment TemperatureBetween 0 and 0 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store below -20 CEL until first use
Handling Environment TemperatureBetween 0 and 0 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100380740193805 [Primary]

FDA Product Code

QKOReagent, coronavirus serological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-14
Device Publish Date2021-04-06

On-Brand Devices [Alinity]

00380740153953Alinity i BRAHMS PCT Reagent Kit 200 Tests
00380740153946Alinity i BRAHMS PCT Controls
00380740153939Alinity i BRAHMS PCT Calibrators
00380740153892Alinity i Anti-TPO Reagent Kit 200 Tests
00380740150600Alinity i Anti-TPO Controls
00380740150594Alinity i Anti-TPO Calibrators
00380740150587Alinity i Anti-Tg Controls
00380740150570Alinity i Anti-Tg Calibrators
00380740149550Alinity i Anti-Tg Reagent Kit 200 Tests
00380740136529Alinity i-series Probe Conditioning Solution
00380740135478Alinity i T-Uptake Controls
00380740131678Alinity i Multi-Assay Manual Diluent
00380740131548Alinity i T-Uptake Reagent Kit 200 Tests
00380740131531Alinity i T-Uptake Calibrators
00380740130862Alinity i CEA Reagent Kit 1200 Tests
00380740130855Alinity i CEA Reagent Kit 200 Tests
00380740130848Alinity i CEA Controls
00380740130831Alinity i CEA Calibrators
00380740130060Alinity i Cortisol Reagent Kit 1000 Tests
00380740130053Alinity i Cortisol Reagent Kit 200 Tests
00380740130046Alinity i Cortisol Calibrators
00380740121143Alinity i-series Concentrated Wash Buffer
00380740118174Alinity Pre-Trigger Solution
00380740118167Alinity Trigger Solution
00380740174927Alinity i STAT CK-MB Reagent Kit 200 Tests
00380740165505Alinity i STAT CK-MB Controls
00380740165482Alinity i STAT CK-MB Calibrators
00380740151300Alinity i Anti-HBs Controls
00380740149611Alinity i Anti-HBs Reagent Kit 1200 Tests
00380740149604Alinity i Anti-HBs Reagent Kit 200 Tests
00380740149598Alinity i Anti-HBs Specimen Diluent
00380740149574Alinity i Anti-HBs Calibrators
00380740136819Alinity s HBsAg Reagent Kit
00380740136802Alinity s HBsAg Release Control Kit
00380740136796Alinity s HBsAg Assay Control Kit
00380740136789Alinity s HBsAg Confirmatory Reagent Kit
00380740136772Alinity s HBsAg Calibrator Kit
00380740130824Alinity i AFP Reagent Kit 1200 Tests
00380740130817Alinity i AFP Reagent Kit 200 Tests
00380740130800Alinity i AFP Controls
00380740130794Alinity i AFP Calibrators
00380740174941Alinity i STAT CK-MB Reagent Kit 1000 Tests
00380740174910Alinity i STAT Myoglobin Reagent Kit 1000 Tests
00380740174903Alinity i STAT Myoglobin Reagent Kit 200 Tests
00380740172282Alinity i STAT Myoglobin Controls
00380740172275Alinity i STAT Myoglobin Calibrators
00380740136895Alinity s Optics Verifier Kit
00380740118181Alinity s Concentrated Wash Buffer
00380740146245Alinity i HBsAg Qualitative II Controls
00380740146238Alinity i HBsAg Qualitative II Calibrators

Trademark Results [Alinity]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ALINITY
ALINITY
97548714 not registered Live/Pending
Matthew Kubicek
2022-08-15
ALINITY
ALINITY
86505125 not registered Dead/Abandoned
Abbott Laboratories
2015-01-15
ALINITY
ALINITY
86505124 5908335 Live/Registered
Abbott Laboratories
2015-01-15
ALINITY
ALINITY
86505123 not registered Dead/Abandoned
Abbott Laboratories
2015-01-15
ALINITY
ALINITY
86505098 not registered Dead/Abandoned
Abbott Laboratories
2015-01-15
ALINITY
ALINITY
86505096 5576114 Live/Registered
Abbott Laboratories
2015-01-15
ALINITY
ALINITY
86505094 5607328 Live/Registered
Abbott Laboratories
2015-01-15
ALINITY
ALINITY
86505092 5601535 Live/Registered
Abbott Laboratories
2015-01-15
ALINITY
ALINITY
86505089 5601534 Live/Registered
Abbott Laboratories
2015-01-15
ALINITY
ALINITY
86505088 5601533 Live/Registered
Abbott Laboratories
2015-01-15
ALINITY
ALINITY
86456946 not registered Dead/Abandoned
WORKFRONT, INC.
2014-11-17
ALINITY
ALINITY
85043533 not registered Dead/Abandoned
JBZ&A, Inc.
2010-05-20

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