MassTrak 186009312IVD
GUDID 00816776020438
MassTrak™ Endocrine Steroid Quality Control Set
WATERS TECHNOLOGIES CORPORATION
Multiple steroid hormone IVD, control| Primary Device ID | 00816776020438 |
| NIH Device Record Key | 36bea0be-e7cb-433e-9342-4c09e5795e52 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MassTrak |
| Version Model Number | 186009312IVD |
| Catalog Number | 186009312IVD |
| 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 | 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 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816776020438 [Primary] |
FDA Product Code
| JJY | Multi-Analyte Controls, All Kinds (Assayed) |
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 | 2021-11-02 |
| Device Publish Date | 2021-10-25 |
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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.