ACL ELITE 00000880311R
GUDID 08426950965572
ACL ELITE (Refurbished)
INSTRUMENTATION LABORATORY COMPANY
Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory| Primary Device ID | 08426950965572 |
| NIH Device Record Key | 0e9525bb-2eac-4216-9e18-cdd922ae3bed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACL ELITE |
| Version Model Number | 00000880311R |
| Catalog Number | 00000880311R |
| Company DUNS | 557223252 |
| Company Name | INSTRUMENTATION LABORATORY COMPANY |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08426950965572 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K060162
FDA Product Code
| JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-07-08 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [ACL ELITE]
| 08426950965572 | ACL ELITE (Refurbished) |
| 08426950453017 | ACL ELITE |
Trademark Results [ACL ELITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACL ELITE 78552589 3269314 Live/Registered |
Instrumentation Laboratory Company 2005-01-24 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.