Synovasure® 00-8888-125-05
GUDID 00887868358821
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 Alpha defensin IVD, kit, rapid ICT, clinical Alpha defensin IVD, kit, rapid ICT, clinical Alpha defensin IVD, kit, rapid ICT, clinical Alpha defensin IVD, kit, rapid ICT, clinical Alpha defensin IVD, kit, rapid ICT, clinical Alpha defensin IVD, kit, rapid ICT, clinical Alpha defensin IVD, kit, rapid ICT, clinical Alpha defensin IVD, kit, rapid ICT, clinical Alpha defensin IVD, kit, rapid ICT, clinical Alpha defensin IVD, kit, rapid ICT, clinical Alpha defensin IVD, kit, rapid ICT, clinical Alpha defensin IVD, kit, rapid ICT, clinical Alpha defensin IVD, kit, rapid ICT, clinical Alpha defensin IVD, kit, rapid ICT, clinical Alpha defensin IVD, kit, rapid ICT, clinical Alpha defensin IVD, kit, rapid ICT, clinical Alpha defensin IVD, kit, rapid ICT, clinical| Primary Device ID | 00887868358821 |
| NIH Device Record Key | 1b44c9a6-5b0c-4f0e-93ea-3b8d3256d006 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Synovasure® |
| Version Model Number | 00-8888-125-05 |
| Catalog Number | 00-8888-125-05 |
| 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 | 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 | 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 | 00887868358821 [Primary] |
| GS1 | 70887868358820 [Unit of Use] |
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 |
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
[00887868358821]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-17 |
| 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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