| Primary Device ID | 00842768001338 | 
| NIH Device Record Key | 16b9433f-02c9-4222-aa10-ff5d37e975b5 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Syva® RapidTest d.a.u.® 9 | 
| Version Model Number | 10445362 | 
| Catalog Number | 6A279UL | 
| Company DUNS | 005088112 | 
| Company Name | Siemens Healthcare Diagnostics Inc. | 
| Device Count | 25 | 
| 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 | 
| Phone | +1(800)227-8994 | 
| XX@XX.XX | |
| Phone | +1(800)227-8994 | 
| XX@XX.XX | |
| Phone | +1(800)227-8994 | 
| XX@XX.XX | |
| Phone | +1(800)227-8994 | 
| XX@XX.XX | |
| Phone | +1(800)227-8994 | 
| XX@XX.XX | |
| Phone | +1(800)227-8994 | 
| XX@XX.XX | |
| Phone | +1(800)227-8994 | 
| XX@XX.XX | |
| Phone | +1(800)227-8994 | 
| XX@XX.XX | |
| Phone | +1(800)227-8994 | 
| XX@XX.XX | |
| Phone | +1(800)227-8994 | 
| XX@XX.XX | |
| Phone | +1(800)227-8994 | 
| XX@XX.XX | |
| Phone | +1(800)227-8994 | 
| XX@XX.XX | |
| Phone | +1(800)227-8994 | 
| XX@XX.XX | |
| Phone | +1(800)227-8994 | 
| XX@XX.XX | |
| Phone | +1(800)227-8994 | 
| XX@XX.XX | |
| Phone | +1(800)227-8994 | 
| XX@XX.XX | |
| Phone | +1(800)227-8994 | 
| XX@XX.XX | |
| Phone | +1(800)227-8994 | 
| XX@XX.XX | |
| Phone | +1(800)227-8994 | 
| XX@XX.XX | |
| Phone | +1(800)227-8994 | 
| XX@XX.XX | |
| Phone | +1(800)227-8994 | 
| XX@XX.XX | |
| Phone | +1(800)227-8994 | 
| XX@XX.XX | |
| Phone | +1(800)227-8994 | 
| XX@XX.XX | |
| Phone | +1(800)227-8994 | 
| XX@XX.XX | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)227-8994 | 
| CONTACT@SIEMENS-HEALTHINEERS.COM | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00630414013961 [Unit of Use] | 
| GS1 | 00842768001338 [Primary] | 
| LFI | HIGH PRESSURE LIQUID CHROMATOGRAPHY, TRICYCLIC ANTIDEPRESSANT DRUGS | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2018-03-29 | 
| Device Publish Date | 2016-09-24 | 
| 00630414320298 - Atellica CH Urine Albumin (UAlb) | 2025-08-19 Atellica CH Microalbumin (UAlb) Reagent | 
| 00630414320304 - Atellica CH UAlb CAL | 2025-08-19 Atellica CH Microalbumin (UAlb) Calibrator | 
| 00630414579108 - ADVIA Centaur ELF Quality Control | 2025-08-18 Enhanced Liver Fibrosis (ELF) QC Kit - ADVIA Centaur - CLT 3 x 3 x 2.0 mL | 
| 00630414598901 - Atellica IM Enhanced Liver Fibrosis Quality Control (ELF QC) | 2025-08-18 Enhanced Liver Fibrosis (ELF) QC Kit - Atellica IM - CLT 3 x 3 x 2.0 mL | 
| 00630414632926 - Atellica IM DHEAS2 100T KIT | 2025-03-28 Atellica IM DHEASII 100T KIT | 
| 00630414632940 - Atellica IM DHEAS2 MCM SET | 2025-03-28 Atellica IM DHEASII MCM SET | 
| 00630414321486 - Atellica IM DHEAS2 (REF) 500T | 2025-03-28 Atellica IM DHEAS2 (REF) 500T Atellica IM-REF Reagent (REF RGT) | 
| 00630414650579 - Atellica IM 1300 Analyzer | 2025-03-24 Recertified Atellica IM 1300 Analyzer | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  SYVA  98806088  not registered Live/Pending | Siemens Healthcare Diagnostics Inc. 2024-10-17 | 
|  SYVA  98783461  not registered Live/Pending | Syva 2024-10-03 | 
|  SYVA  79210774  5372298 Live/Registered | L-ACOUSTICS 2017-03-30 | 
|  SYVA  76136850  2602378 Live/Registered | SIEMENS HEALTHCARE DIAGNOSTICS INC. 2000-09-28 | 
|  SYVA  74421581  1836538 Live/Registered | SIEMENS HEALTHCARE DIAGNOSTICS INC. 1993-08-04 | 
|  SYVA  74421327  1839210 Dead/Cancelled | SYVA COMPANY 1993-08-04 | 
|  SYVA  74387980  1864604 Live/Registered | Siemens Healthcare Diagnostics Inc. 1993-05-10 | 
|  SYVA  74387976  1909771 Dead/Cancelled | SYVA DIAGNOSTICS HOLDING COMPANY 1993-05-10 | 
|  SYVA  74387813  1820899 Dead/Cancelled | SYVA COMPANY 1993-05-10 | 
|  SYVA  74272364  1761310 Dead/Cancelled | SYVA COMPANY 1992-05-04 | 
|  SYVA  74270082  1765835 Dead/Cancelled | SYVA COMPANY 1992-04-28 | 
|  SYVA  73763803  1548087 Live/Registered | SYVA COMPANY 1988-11-14 |