Stratus® CS STAT Fluorometric Analyzer Sample Cups CCUPS
GUDID 00842768004551
Stratus® CS STAT Fluorometric Analyzer sample cups are used to introduce quality control (QC) material or previously centrifuged plasma for processing.
Siemens Healthcare Diagnostics Inc.
General laboratory container, single-use, non-sterile| Primary Device ID | 00842768004551 |
| NIH Device Record Key | ac4597cf-050f-471a-b98d-9e16d9594b95 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stratus® CS STAT Fluorometric Analyzer Sample Cups |
| Version Model Number | 10445074 |
| Catalog Number | CCUPS |
| Company DUNS | 005088112 |
| 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
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414009889 [Unit of Use] |
| GS1 | 00842768004551 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K984067
FDA Product Code
| JHX | FLUOROMETRIC METHOD, CPK OR ISOENZYMES |
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.
| 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 |
| 00630414650623 - Atellica IM 1600 Analyzer | 2025-03-24 Recertified Atellica IM 1600 Analyzer |
| 00630414313429 - Atellica CH Diazo Direct Bilirubin (D_DBil) | 2024-10-24 Atellica CH Diazo Direct Bilirubin (D_TBil) |
| 00630414313436 - Atellica CH Diazo Total Bilirubin (D_TBil) | 2024-10-24 Atellica CH Diazo Total Bilirubin (D_TBil) |
| 00630414317472 - Atellica Connect | 2024-09-19 |
Trademark Results [Stratus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STRATUS 98753605 not registered Live/Pending |
Parata Systems, LLC 2024-09-16 |
 STRATUS 98750170 not registered Live/Pending |
InterVene, Inc. 2024-09-13 |
 STRATUS 98639678 not registered Live/Pending |
Roto Foundry, LLC 2024-07-09 |
 STRATUS 98563829 not registered Live/Pending |
GTP Services, LLC 2024-05-22 |
 STRATUS 98533758 not registered Live/Pending |
GTP Services, LLC 2024-05-03 |
 STRATUS 97939645 not registered Live/Pending |
Stratus Team LLC 2023-05-16 |
 STRATUS 97855538 not registered Live/Pending |
Culligan International Compan 2023-03-24 |
 STRATUS 97701645 not registered Live/Pending |
ICP, Inc. 2022-12-02 |
 STRATUS 97653579 not registered Live/Pending |
RJ Whyte Event Production LLC 2022-10-28 |
 STRATUS 97642075 not registered Live/Pending |
Stratus Metals, Inc. 2022-10-21 |
 STRATUS 97642056 not registered Live/Pending |
Stratus Metals, Inc. 2022-10-21 |
 STRATUS 97642044 not registered Live/Pending |
Stratus Metals, Inc. 2022-10-21 |
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