Aggreguide
AggreDYNE A-100 ADP Assay
1manufacturer
2catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
Record
| Listed by | Aggredyne, Inc., United States |
|---|---|
| FDA product code | JOZ |
| Device type | System, Automated Platelet Aggregation |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5700 |
| Record published | 2019-09-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 15 to 25 °C |
| Packaging | Case of 20, kit |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A-100 | In distribution | |
| A-100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| VerifyNow System | Accriva Diagnostics, Inc. | 12 |
| Chrono-log | Chrono-LOG Corp. | 10 |
| TEG6s Hemostasis System | Haemonetics Corporation | 5 |
| VerifyNow Platelet Reactivity Test | Accriva Diagnostics, Inc. | 4 |
| TEG Hemostasis System | Haemonetics Corporation | 3 |
| TEG5000 Hemostasis System | Haemonetics Corporation | 3 |
| AggRecetin | Bio/Data Corp. | 2 |
| Plateletworks Combo-25 Kit | Helena Laboratories, Corp. | 1 |
| Epinephrine | Bio/Data Corp. | 1 |
| Bapa tube | Zacros Corporation | 1 |
| T-TAS 01 Total Thrombus Formation Analysis System | Zacros Corporation | 1 |
| PL Chip for T-TAS 01 | Zacros Corporation | 1 |
Showing 12 of 34. All products under System, Automated Platelet Aggregation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181777 | 2019-03-29 |
| K163274 | 2017-04-05 |
| K122162 | 2013-12-20 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Aggredyne, Inc. | UDI-DI | 2019-07-23 | Class II | Software design | The firm identified a software design issue where the improper shut down of the instrument resulted in speeds.csv file contents of the software version 5.1 being erased. Due to this issue, the target RPM for the assay is 0 and the motor out | 47 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.