VersaCell® X3 10793839
GUDID 00630414595177
VERSACELL X3 Instrument
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
Specimen processing instrument IVD, automated| Primary Device ID | 00630414595177 |
| NIH Device Record Key | 19e74a30-2cf9-4414-903a-cc3ceb65d4c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VersaCell® X3 |
| Version Model Number | 10793839 |
| Catalog Number | 10793839 |
| Company DUNS | 186812384 |
| Company Name | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414595177 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K970227
FDA Product Code
| JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-25 |
| Device Publish Date | 2018-09-24 |
Devices Manufactured by SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
| 00630414972923 - IMMULITE®2000 Systems Diluent Tube Caps | 2020-10-02 |
| 00630414973159 - IMMULITE® 2000 Systems Diluent Tubes | 2020-10-02 |
| 00630414974064 - IMMULITE® 2000 Systems Microsampling Tube Caps | 2020-10-02 |
| 00630414974194 - IMMULITE® 1000 Systems1000 Sample Cup Caps | 2020-10-02 |
| 00630414973937 - IMMULITE® 2000 Systems Microsampling Tubes | 2019-02-06 Microsampling Tubes - IMMULITE - CONS - 1000 Pieces |
| 00630414974187 - IMMULITE®/IMMULITE® 1000 Systems SAMPLE CUPS | 2019-02-04 IMMULITE Sample Cups(1000/pack) - IMMULITE - CONS - 1000 Pieces |
| 00630414947440 - IMMULITE® 1000 Immunoassay System | 2019-01-23 IMMULITE® 1000 Instrument, 110 VOLT |
| 00630414595177 - VersaCell® X3 | 2018-10-25VERSACELL X3 Instrument |
| 00630414595177 - VersaCell® X3 | 2018-10-25 VERSACELL X3 Instrument |
Trademark Results [VersaCell]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VERSACELL 77379173 3841983 Live/Registered |
Siemens Healthcare Diagnostics Inc. 2008-01-24 |
 VERSACELL 75085727 2054885 Dead/Cancelled |
SUN CHEMICAL CORPORATION 1996-04-09 |
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