ACL ELITE 00000880311
GUDID 08426950453017
ACL ELITE
INSTRUMENTATION LABORATORY COMPANY
Coagulation analyser IVD, laboratory, automated| Primary Device ID | 08426950453017 |
| NIH Device Record Key | d09fb94d-f239-42b0-9fb7-a1704b533ca6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACL ELITE |
| Version Model Number | 00000880311 |
| Catalog Number | 00000880311 |
| 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 | true |
| 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 | 08426950453017 [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 |
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