Acceava®
GUDID 10815845020031
ALERE SAN DIEGO, INC.
Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical| Primary Device ID | 10815845020031 |
| NIH Device Record Key | 53193335-1dbf-40ac-89ba-1d03712dc4c3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Acceava® |
| Version Model Number | 92001 |
| Company DUNS | 194854949 |
| Company Name | ALERE SAN DIEGO, INC. |
| Device Count | 50 |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 866-216-0094 |
| xx@xx.xx | |
| Phone | 866-216-0094 |
| xx@xx.xx | |
| Phone | 866-216-0094 |
| xx@xx.xx | |
| Phone | 866-216-0094 |
| xx@xx.xx | |
| Phone | 866-216-0094 |
| xx@xx.xx | |
| Phone | 866-216-0094 |
| xx@xx.xx | |
| Phone | 866-216-0094 |
| xx@xx.xx | |
| Phone | 866-216-0094 |
| xx@xx.xx | |
| Phone | 866-216-0094 |
| xx@xx.xx | |
| Phone | 866-216-0094 |
| xx@xx.xx | |
| Phone | 866-216-0094 |
| xx@xx.xx | |
| Phone | 866-216-0094 |
| xx@xx.xx | |
| Phone | 866-216-0094 |
| xx@xx.xx | |
| Phone | 866-216-0094 |
| xx@xx.xx | |
| Phone | 866-216-0094 |
| xx@xx.xx | |
| Phone | 866-216-0094 |
| xx@xx.xx | |
| Phone | 866-216-0094 |
| xx@xx.xx | |
| Phone | 866-216-0094 |
| xx@xx.xx | |
| Phone | 866-216-0094 |
| xx@xx.xx | |
| Phone | 866-216-0094 |
| xx@xx.xx | |
| Phone | 866-216-0094 |
| xx@xx.xx | |
| Phone | 866-216-0094 |
| xx@xx.xx | |
| Phone | 866-216-0094 |
| xx@xx.xx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815845020034 [Unit of Use] |
| GS1 | 10815845020031 [Primary] |
FDA Product Code
| GTY | Antigens, All Groups, Streptococcus Spp. |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2022-06-10 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [Acceava®]
| 10815845020031 | 92001 |
| 10815845020017 | 92404 |
Trademark Results [Acceava]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCEAVA 75308530 2241201 Live/Registered |
ALERE SAN DIEGO, INC. 1997-06-13 |
 ACCEAVA 75308336 2241963 Live/Registered |
ALERE SAN DIEGO, INC. 1997-06-13 |
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