MassTrak™ Immunosuppresant Kit 186002891

GUDID 00816776020001

The MassTrak™ Immunosuppressants Kit is an in vitro diagnostic device that is comprised of six (6) calibrators, three (3) quality controls, one (1) internal standard, one (1) neat solution. The MassTrak Immunosuppressants Kit is indicated for the quantification of the immunosuppressive drug Tacrolimus (FK506; Prograf) in liver and kidney transplant patient whole blood samples as an aid in the management of Tacrolimus therapy. The kit is verified for use with Waters LC-MS systems, liquid chromatograph coupled to mass spectrometer.

WATERS TECHNOLOGIES CORPORATION

Tacrolimus therapeutic drug monitoring IVD, control
Primary Device ID00816776020001
NIH Device Record Key14498904-04ed-463b-854c-d2ce3daa3a69
Commercial Distribution StatusIn Commercial Distribution
Brand NameMassTrak™ Immunosuppresant Kit
Version Model NumberF
Catalog Number186002891
Company DUNS107186004
Company NameWATERS TECHNOLOGIES CORPORATION
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com
Phone1-800-252-4752
Emailcustomerservice@waters.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816776020001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MLMEnzyme Immunoassay, Tracrolimus

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by WATERS TECHNOLOGIES CORPORATION

00816776020247 - MassTrak2024-02-02 MassTrak Endocrine Blank Calibrator
00816776020544 - MassTrak2023-12-13 MassTrak™ Steroid Serum Cal Set 2
00816776020551 - MassTrak2023-12-13 MassTrak™ Steroid Serum QC Set 2
00816776020568 - MassTrak2023-12-13 MassTrak™ Steroid Serum Cal Set 3
00816776020575 - MassTrak2023-12-13 MassTrak™ Steroid Serum QC Set 3
00816776020582 - MassTrak2023-12-13 MassTrak™ Steroid Optimization Mix
00816776020599 - MassTrak2023-12-13 MassTrak™ Steroid Internal Standard Mix
00816776020254 - Xevo2023-04-14

Trademark Results [MassTrak]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MASSTRAK
MASSTRAK
97049248 not registered Live/Pending
Waters Technologies Corporation
2021-09-28
MASSTRAK
MASSTRAK
87714017 not registered Live/Pending
Waters Technologies Corporation
2017-12-08
MASSTRAK
MASSTRAK
78310001 not registered Dead/Abandoned
Peak Sensor Systems
2003-10-06

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