Multistix® 9 Reagent Strips 2162
GUDID 00630414549019
Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (acetoacetic acid), pH, bilirubin and urobilinogen
Siemens Healthcare Diagnostics Inc.
Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical| Primary Device ID | 00630414549019 |
| NIH Device Record Key | 8823f05c-7708-4ea0-bd21-b30d048ba926 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Multistix® 9 Reagent Strips |
| Version Model Number | 10329874 |
| Catalog Number | 2162 |
| Company DUNS | 064608573 |
| Company Name | Siemens Healthcare Diagnostics Inc. |
| Device Count | 100 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414009629 [Unit of Use] |
| GS1 | 00630414549019 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K992257
FDA Product Code
| JRE | REFRACTOMETER FOR CLINICAL USE |
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 Siemens Healthcare Diagnostics Inc.
| 00630414313450 - Atellica CH Billirubin Calibrator (BILI CAL) | 2024-04-11 Atellica CH Bilirubin Calibrator (BILI CAL) |
| 00630414317427 - Clinistix UTI Test Strips | 2024-02-29 Test strips for urinary tract infection |
| 00630414626963 - ADVIA Centaur NT-PBNPII (PBNPII) | 2024-02-13 PBNPII - ADVIA Centaur - MCM Set |
| 00630414626970 - ATELLICA IM NT-PBNPII (PBNPII) | 2024-02-13 PBNPII - ATELLICA IM - MCM Set |
| 00630414284927 - ADVIA Centaur PBNPII | 2024-02-12 NT-proBNPII (PBNPII) - ADVIA Centaur - RGT - 100T |
| 00630414284934 - ADVIA Centaur PBNPII | 2024-02-12 NT-proBNPII (PBNPII) - ADVIA Centaur - RGT - 500T |
| 00630414284941 - Atellica IM PBNPII | 2024-02-12 NT-proBNPII (PBNPII) - Atellica IM - RGT - 100T |
| 00630414284958 - Atellica IM PBNPII | 2024-02-12 NT-proBNPII (PBNPII) - Atellica IM - RGT - 500T |
Trademark Results [Multistix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MULTISTIX 72407137 0947477 Live/Registered |
MILES LABORATORIES, INC. 1971-11-08 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.