Alinity 08P3121

GUDID 00380740136215

Alinity i Intact PTH Reagent Kit 200 Tests

Abbott GmbH & Co. KG

Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
Primary Device ID00380740136215
NIH Device Record Keye6b31eaf-b98b-4dc3-964a-bb9b4f7b8ef8
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlinity
Version Model Number08P3121
Catalog Number08P3121
Company DUNS315786293
Company NameAbbott GmbH & Co. KG
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
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 HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100380740136215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CEWRADIOIMMUNOASSAY, PARATHYROID HORMONE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-23
Device Publish Date2018-10-24

On-Brand Devices [Alinity]

00380740166441Alinity c Lithium Assay File
00380740162832Alinity c Bili Total Assay File
00380740161941Alinity c UIBC Assay File
00380740160807Alinity i B_hCG Assay File
00380740160791Alinity c Iron Assay File
00380740158460Alinity ci-series Reagent Cartridge, Black (Large)
00380740158422Alinity c Total Bilirubin Reagent Kit 3600 Tests
00380740158415Alinity c Total Bilirubin Reagent Kit 2750 Tests
00380740155919Alinity i CA 19-9XR Reagent Kit 200 Tests
00380740155797Alinity i tHCY-DIL Assay File
00380740154493Alinity i C-Peptide Reagent Kit 200 Tests
00380740154486Alinity i Homocysteine Controls
00380740154479Alinity i Homocysteine Calibrators
00380740154462Alinity i C-Peptide Calibrators
00380740154325Alinity c Lipid Multiconstituent Calibrator Kit
00380740153526Alinity i C-Peptide Controls
00380740153496Alinity i Homocysteine Reagent Kit 200 Tests
00380740153458Alinity c-series Detergent B
00380740152864Alinity c Iron Calibrator Kit
00380740152123Alinity c Valproic Assay File
00380740152109Alinity c Tobra Assay File
00380740152093Alinity c Theo Assay File
00380740152062Alinity c Prealbumin Assay File
00380740152055Alinity c Phenobarb Assay File
00380740151843Alinity c ASO Assay File
00380740151812Alinity c Amikacin Assay File
00380740151799Alinity c a1AT Assay File
00380740151768Alinity c B2M Assay File
00380740151737Alinity i SHBG Assay File
00380740151706Alinity i Progest Assay File
00380740151690Alinity i PCT Assay File
00380740151621Alinity i LH Assay File
00380740151614Alinity i Insulin Assay File
00380740151607Alinity i tHCY-UNDIL Assay File
00380740151553Alinity i FSH Assay File
00380740151485Alinity i C-Peptide Assay File
00380740151447Alinity i VitB12 Assay File
00380740151430Alinity i Anti-TPO Assay File
00380740151423Alinity i Anti-Tg Assay File
00380740151416Alinity i Anti-CCP Assay File
00380740151393Alinity i SHBG Reagent Kit
00380740151386Alinity i SHBG Controls
00380740151379Alinity i SHBG Calibrators
00380740151362Alinity i Anti-CCP Reagent Kit 200 Tests
00380740151355Alinity i Anti-CCP Controls
00380740151348Alinity i Anti-CCP Calibrators
00380740151256Alinity c Prealbumin Calibrator Kit
00380740151089Alinity c Specific Proteins Multiconstituent Calibrator Kit
00380740150914Alinity i Testo 2G Assay File
00380740150815Alinity i Insulin Reagent Kit 200 Tests

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.