Alinity 08P5520

GUDID 00380740135522

Alinity c Gentamicin Reagent Kit 200 Tests

ABBOTT LABORATORIES

Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Primary Device ID00380740135522
NIH Device Record Keyc524b217-0fea-431b-a332-10b89d8a9159
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlinity
Version Model Number08P5520
Catalog Number08P5520
Company DUNS079226220
Company NameABBOTT LABORATORIES
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 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
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

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 0 and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 0 and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100380740135522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCDENZYME IMMUNOASSAY, GENTAMICIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-31
Device Publish Date2018-12-31

On-Brand Devices [Alinity]

00380740157302Alinity c TDM Multiconstituent Calibrator Kit
00380740156848Alinity c-series Reagent Cartridge, Clear (Large)
00380740156831Alinity Diagnostics Kit
00380740156824Alinity i Maintenance Cleaning Cartridge
00380740154295Alinity c Clinical Chemistry Calibrator Kit
00380740154158Alinity c Valproic Acid Reagent Kit 200 Tests
00380740154141Alinity c Tobramycin Reagent Kit 200 Tests
00380740154134Alinity c Tobramycin Calibrators
00380740154127Alinity c Theophylline Reagent Kit 200 Tests
00380740154110Alinity c Phenobarbital Reagent Kit 200 Tests
00380740154103Alinity c Amikacin Reagent Kit 200 Tests
00380740153755Alinity c ASO Control II
00380740153748Alinity c ASO Control I
00380740153724Alinity c Proteins Control Kit
00380740153717Alinity c Proteins Calibrators
00380740153601Alinity c B2-Microglobulin Reagent Kit 200 Tests
00380740153588Alinity c B2-Microglobulin Calibrator
00380740153564Alinity c ASO Reagent Kit 300 Tests
00380740153540Alinity c ASO Calibrator
00380740153519Alinity c A1-Antitrypsin Reagent Kit 200 Tests
00380740136277Alinity c Lithium Reagent Kit 190 Tests
00380740136260Alinity c UIBC Calibrator Kit
00380740136253Alinity c Iron Reagent Kit 2300 Tests
00380740136192Alinity c Ammonia Ultra Reagent Kit
00380740136185Alinity c Ammonia Controls
00380740136178Alinity c Creatinine (Enzymatic) Reagent Kit 3600 Tests
00380740136161Alinity c Creatinine (Enzymatic) Reagent Kit 1440 Tests
00380740135614Alinity c Salicylate Reagent Kit 200 Tests
00380740135607Alinity c Salicylate Calibrator Kit
00380740135522Alinity c Gentamicin Reagent Kit 200 Tests
00380740135515Alinity c Phenytoin Reagent Kit 400 Tests
00380740135386Alinity c Ethanol Reagent Kit 200 Tests
00380740135379Alinity c Ethanol Control Kit
00380740135355Alinity c Ethanol Calibrator Kit
00380740135348Alinity c Vancomycin Reagent Kit 400 Tests
00380740135324Alinity c Digoxin Reagent Kit 800 Tests
00380740129972Alinity c Direct LDL Reagent Kit
00380740121891Alinity c UIBC Reagent Kit 300 Tests
00380740153809Alinity c A-1-AGP Reagent Kit 200 Tests
00380740135393Alinity c Ethanol Reagent Kit 400 Tests
00380740153847Alinity c Lp(a) Reagent Kit 200 Tests
00380740153823Alinity c Lp(a) Control Kit
00380740153816Alinity c Lp(a) Calibrators
00380740151317Alinity c Plasmaproteins Cal 3x Kit
00380740174880Alinity c DOA MC Negative Calibrator Kit
00380740172329Alinity c Amphetamine/Methamphetamine Reagent Kit 400 Tests
00380740165529Alinity c DOA MC Semiquant Calibrator Kit
00380740165512Alinity c DOA MC Qual Calibrator 2 Kit
00380740165345Alinity c DOA MC III Controls
00380740165321Alinity c DOA MC I Controls

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

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