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 ID | 00816776020001 |
| NIH Device Record Key | 14498904-04ed-463b-854c-d2ce3daa3a69 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MassTrak™ Immunosuppresant Kit |
| Version Model Number | F |
| Catalog Number | 186002891 |
| Company DUNS | 107186004 |
| Company Name | WATERS TECHNOLOGIES CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816776020001 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K063868
FDA Product Code
| MLM | Enzyme Immunoassay, Tracrolimus |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
Devices Manufactured by WATERS TECHNOLOGIES CORPORATION
| 00816776020247 - MassTrak | 2024-02-02 MassTrak Endocrine Blank Calibrator |
| 00816776020544 - MassTrak | 2023-12-13 MassTrak™ Steroid Serum Cal Set 2 |
| 00816776020551 - MassTrak | 2023-12-13 MassTrak™ Steroid Serum QC Set 2 |
| 00816776020568 - MassTrak | 2023-12-13 MassTrak™ Steroid Serum Cal Set 3 |
| 00816776020575 - MassTrak | 2023-12-13 MassTrak™ Steroid Serum QC Set 3 |
| 00816776020582 - MassTrak | 2023-12-13 MassTrak™ Steroid Optimization Mix |
| 00816776020599 - MassTrak | 2023-12-13 MassTrak™ Steroid Internal Standard Mix |
| 00816776020254 - Xevo | 2023-04-14 |
Trademark Results [MassTrak]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MASSTRAK 97049248 not registered Live/Pending |
Waters Technologies Corporation 2021-09-28 |
 MASSTRAK 87714017 not registered Live/Pending |
Waters Technologies Corporation 2017-12-08 |
 MASSTRAK 78310001 not registered Dead/Abandoned |
Peak Sensor Systems 2003-10-06 |
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