| Primary Device ID | 00817089021181 |
| NIH Device Record Key | dca5800c-8428-4f97-85b8-3fc32753a893 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Diazyme |
| Version Model Number | DZ132A-KY1 |
| Company DUNS | 080507219 |
| Company Name | DIAZYME LABORATORIES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817089021181 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-11-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DIAZYME 76016954 2586200 Live/Registered |
General Atomics, Inc. 2000-04-03 |
![]() DIAZYME 74344385 1800360 Live/Registered |
DANISCO US INC. 1992-12-30 |
![]() DIAZYME 71147806 0172650 Live/Registered |
Takamine Laboratory, Inc. 1921-05-16 |