ACE Alera® 402900-1
GUDID 00857969006693
ACE Alera Clinical Chemistry System with ISE
ALFA WASSERMANN, INC.
Multichannel clinical chemistry analyser IVD, point-of-care, line-powered| Primary Device ID | 00857969006693 |
| NIH Device Record Key | 8ba14d9a-efa8-4d1a-b81a-0f3a56f88149 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACE Alera® |
| Version Model Number | 402900-1 |
| Catalog Number | 402900-1 |
| Company DUNS | 781990924 |
| Company Name | ALFA WASSERMANN, 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 | false |
| Serial Number | false |
| 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
| Phone | 973-852-0178 |
| AGennis@alfawassermannus.com | |
| Phone | 973-852-0178 |
| AGennis@alfawassermannus.com | |
| Phone | 973-852-0178 |
| AGennis@alfawassermannus.com | |
| Phone | 973-852-0178 |
| AGennis@alfawassermannus.com | |
| Phone | 973-852-0178 |
| AGennis@alfawassermannus.com | |
| Phone | 973-852-0178 |
| AGennis@alfawassermannus.com | |
| Phone | 973-852-0178 |
| AGennis@alfawassermannus.com | |
| Phone | 973-852-0178 |
| AGennis@alfawassermannus.com | |
| Phone | 973-852-0178 |
| AGennis@alfawassermannus.com | |
| Phone | 973-852-0178 |
| AGennis@alfawassermannus.com | |
| Phone | 973-852-0178 |
| AGennis@alfawassermannus.com | |
| Phone | 973-852-0178 |
| AGennis@alfawassermannus.com | |
| Phone | 973-852-0178 |
| AGennis@alfawassermannus.com | |
| Phone | 973-852-0178 |
| AGennis@alfawassermannus.com | |
| Phone | 973-852-0178 |
| AGennis@alfawassermannus.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857969006693 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123018
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 | 2021-01-15 |
| Device Publish Date | 2021-01-07 |
Devices Manufactured by ALFA WASSERMANN, INC.
| 00857969006693 - ACE Alera® | 2021-01-15ACE Alera Clinical Chemistry System with ISE |
| 00857969006693 - ACE Alera® | 2021-01-15 ACE Alera Clinical Chemistry System with ISE |
| 00857969006709 - ACE Axcel® | 2021-01-15 ACE Axcel Clinical Chemistry System with ISE |
| 00857969006662 - ACE | 2020-07-09 ALT Reagent |
| 00857969006679 - ACE | 2020-07-09 AST Reagent |
| 00857969006686 - ACE | 2020-07-09 AST Reagent |
| 00857969006624 - ACE | 2020-04-17 NORMAL SALINE DILUENT |
| 00857969006631 - ACE | 2020-04-17 SYSTEM DILUENT |
| 00857969006648 - ACE | 2020-04-17 ISE WASH |
Trademark Results [ACE Alera]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACE ALERA 78345133 3016230 Live/Registered |
Alfa Wassermann, Inc. 2003-12-23 |
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