Synovasure® 00-8888-125-02
GUDID 00887868358852
CD DIAGNOSTICS, INC.
Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid Alpha defensin 1-3 IVD, kit, rapid ICT, clinical Alpha defensin 1-3 IVD, kit, rapid ICT, clinical Alpha defensin 1-3 IVD, kit, rapid ICT, clinical Alpha defensin 1-3 IVD, kit, rapid ICT, clinical Alpha defensin 1-3 IVD, kit, rapid ICT, clinical Alpha defensin 1-3 IVD, kit, rapid ICT, clinical| Primary Device ID | 00887868358852 |
| NIH Device Record Key | 593ce457-249b-4e37-a4d6-243cde0cc05e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Synovasure® |
| Version Model Number | 00-8888-125-02 |
| Catalog Number | 00-8888-125-02 |
| Company DUNS | 027871090 |
| Company Name | CD DIAGNOSTICS, INC. |
| Device Count | 1 |
| 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 | false |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868358852 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN180032
FDA Product Code
| QGN | Lateral Flow Immunochromatography Assay For Host Infection Biomarkers |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
[00887868358852]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-07-23 |
| Device Publish Date | 2019-07-09 |
On-Brand Devices [Synovasure®]
| 00887868358852 | 00-8888-125-02 |
| 00887868358845 | 00-8888-125-30 |
| 00887868358838 | 00-8888-125-10 |
| 00887868358821 | 00-8888-125-05 |
| 00887868358814 | 00-8888-125-01 |
Trademark Results [Synovasure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYNOVASURE 90905858 not registered Live/Pending |
Zimmer, Inc. 2021-08-27 |
 SYNOVASURE 85765612 4506612 Live/Registered |
Zimmer, Inc. 2012-10-29 |
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