MassTrak 186010251IVD
GUDID 00816776020513
MassTrak™ Immunosuppressant Calibrator Set
WATERS TECHNOLOGIES CORPORATION
Multiple immunosuppressant therapeutic drug monitoring IVD, calibrator| Primary Device ID | 00816776020513 |
| NIH Device Record Key | d2b0872e-c656-4a89-b2ad-52b4f0983472 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MassTrak |
| Version Model Number | 186010251IVD |
| Catalog Number | 186010251IVD |
| Company DUNS | 107186004 |
| Company Name | WATERS TECHNOLOGIES CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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
| Phone | 1-800-252-4752 |
| customerservice@waters.com | |
| Phone | 1-800-252-4752 |
| customerservice@waters.com | |
| Phone | 1-800-252-4752 |
| customerservice@waters.com | |
| Phone | 1-800-252-4752 |
| customerservice@waters.com | |
| Phone | 1-800-252-4752 |
| customerservice@waters.com | |
| Phone | 1-800-252-4752 |
| customerservice@waters.com | |
| Phone | 1-800-252-4752 |
| customerservice@waters.com | |
| Phone | 1-800-252-4752 |
| customerservice@waters.com | |
| Phone | 1-800-252-4752 |
| customerservice@waters.com | |
| Phone | 1-800-252-4752 |
| customerservice@waters.com | |
| Phone | 1-800-252-4752 |
| customerservice@waters.com | |
| Phone | 1-800-252-4752 |
| customerservice@waters.com | |
| Phone | 1-800-252-4752 |
| customerservice@waters.com | |
| Phone | 1-800-252-4752 |
| customerservice@waters.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816776020513 [Primary] |
FDA Product Code
| JIX | Calibrator, Multi-Analyte Mixture |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-13 |
| Device Publish Date | 2022-04-05 |
On-Brand Devices [MassTrak]
| 00816776020438 | MassTrak™ Endocrine Steroid Quality Control Set |
| 00816776020421 | MassTrak™ Endocrine Steroid Calibrator Set |
| 00816776020292 | MassTrak TDM C18 2.1x10mm Column, IVD |
| 00816776020537 | MassTrak™ Immunosuppressant Internal Standard Set |
| 00816776020520 | MassTrak™ Immunosuppressant Quality Control Set |
| 00816776020513 | MassTrak™ Immunosuppressant Calibrator Set |
| 00816776020599 | MassTrak™ Steroid Internal Standard Mix |
| 00816776020582 | MassTrak™ Steroid Optimization Mix |
| 00816776020575 | MassTrak™ Steroid Serum QC Set 3 |
| 00816776020568 | MassTrak™ Steroid Serum Cal Set 3 |
| 00816776020551 | MassTrak™ Steroid Serum QC Set 2 |
| 00816776020544 | MassTrak™ Steroid Serum Cal Set 2 |
| 00816776020247 | MassTrak Endocrine Blank Calibrator |
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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