Dade® PFA Collagen/ADP Test Cartridge B4170-21A
GUDID 00842768003684
To aid in the detection of platelet dysfunction in citrated human whole blood
Siemens Healthcare Diagnostics Products GmbH
Platelet aggregation study IVD, kit, nephelometry/turbidimetry| Primary Device ID | 00842768003684 |
| NIH Device Record Key | be07d632-919b-4372-9ddd-3ca91f22ba44 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dade® PFA Collagen/ADP Test Cartridge |
| Version Model Number | 10445699 |
| Catalog Number | B4170-21A |
| Company DUNS | 388240673 |
| Company Name | Siemens Healthcare Diagnostics Products GmbH |
| Device Count | 20 |
| 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 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842768003684 [Primary] |
| GS1 | 00842768019784 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K060489
FDA Product Code
| JOZ | SYSTEM, AUTOMATED PLATELET AGGREGATION |
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 Products GmbH
| 00630414240336 - INNOVANCE Apixaban Controls | 2024-12-04 INNOVANCE Apixaban Controls |
| 00630414240343 - INNOVANCE Apixaban Standards | 2024-12-04 INNOVANCE Apixaban Standards |
| 00630414240404 - INNOVANCE Anti-Xa | 2024-12-04 In-vitro diagnostic automated assay for the quantitative determination of UFH and LMWH activity in human citrated plasma. |
| 00842768018800 - BC von Willebrand Reagent | 2024-09-20 Determination of ristocetin co-factor activity of von Willebrand factor in human plasma through platelet agglutination |
| 00842768019661 - LA 2 Confirmation Reagent | 2024-04-08 LA 2 Confirmation Reagent. Phospholipid-rich DRVV reagent for the specific correction of Lupus Anticoagulants |
| 00842768019654 - LA 1 Screening Reagent | 2024-04-08 LA 1 Screening Reagent. Simplified DRVV reagent to screen for the presence of Lupus Anticoagulants |
| 00842768019678 - LA Control Low | 2024-04-08 LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays |
| 00842768019685 - LA Control High | 2024-04-08 LA Control High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays |
Trademark Results [Dade]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DADE 97004218 not registered Live/Pending |
Hernandez, Abnel 2021-08-31 |
 DADE 86034975 4616131 Live/Registered |
GUANGDONG JIYU PORCELAIN CORP., LTD. 2013-08-12 |
 DADE 75036129 2245269 Live/Registered |
Siemens Healthcare Diagnostics Inc. 1995-12-22 |
 DADE 74100946 1687376 Dead/Cancelled |
Aldi Inc. 1990-09-27 |
 DADE 73192744 1143179 Dead/Cancelled |
American Hospital Supply Corporation 1978-11-09 |
 DADE 73182644 1138626 Dead/Cancelled |
T.K. PRODUCTIONS, INC. 1978-08-18 |
 DADE 72336910 0913150 Dead/Expired |
AMERICAN HOSPITAL SUPPLY CORPORATION 1969-09-03 |
 DADE 72328146 0892303 Live/Registered |
AMERICAN HOSPITAL SUPPLY CORPORATION 1969-05-23 |
 DADE 71687854 0643431 Dead/Expired |
DADE REAGENTS, INC. 1955-05-19 |
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