| Primary Device ID | 20883489001935 |
| NIH Device Record Key | aef117fd-0c22-446d-a06b-fbf4e36a309f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RIGHTEST GT333 Control Solution |
| Version Model Number | Level 2 |
| Company DUNS | 658637244 |
| Company Name | BIONIME CORPORATION |
| 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 | 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 | true |
| Phone | 1 909 781 6969 |
| info@bionimeusa.com |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00883489001924 [Primary] |
| GS1 | 00883489001931 [Package] Contains: 00883489001924 Package: Paper [1 Units] In Commercial Distribution |
| GS1 | 10883489001938 [Package] Contains: 00883489001931 Package: paper [120 Units] In Commercial Distribution |
| GS1 | 20883489001935 [Package] Contains: 10883489001938 Package: paper [6 Units] In Commercial Distribution |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-16 |
| Device Publish Date | 2019-10-08 |
| 00883489002525 - SMARTMETER | 2024-01-26 kit only has one meter |
| 00883489002501 - SMARTMETER | 2023-12-25 Control Solution-Level 2 |
| 00883489001306 - RIGHTEST | 2023-07-11 single lancing device |
| 00883489001320 - GE | 2023-07-11 GE Lancing device |
| 20883489002383 - ODM | 2020-01-27 1 meter - 00883489002372 |
| 00883489002396 - ODM | 2020-01-27 1 meter - 00883489002396 |
| 20883489002420 - ODM | 2020-01-27 25 strips - 80883489002415 |
| 00883489001504 - ODM | 2020-01-06 The combination products includes 1 pce of lancing device_GD500(00883489001566), 1 pc of control solution(00883489001580),10 pcs |