| Primary Device ID | 06935784400026 |
| NIH Device Record Key | 213076e3-fa8b-43a4-822d-4bed37d85b9f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioHermes A1cChek Pro Glycohemoglobin Analyzer |
| Version Model Number | A1C EZ Auto 4 W |
| Catalog Number | A1C-M31 |
| Company DUNS | 528192913 |
| Company Name | Wuxi Biohermes Bio & Medical Technology Co.,Ltd. |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06935784400026 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-02 |
| Device Publish Date | 2021-05-25 |
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| 16935784420267 - BioHermes GluCoA1c Blood Glucose and Glycohemoglobin Analyzer | 2022-09-05 GluCoA1c Blood Glucose and Glycohemoglobin Analyzer. Intended use: GluCoA1c analyzer is for use with GluCoA1c Glycohemoglobin Te |
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| 06935784430016 - BioHermes Automated Glycohemoglobin Analyzer | 2022-01-12 The BH60 Automated Glycohemoglobin Analyzer is intended for in vitro diagnostic use for the quantitative measurement of HbA1c in |
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| 06935784400026 - BioHermes A1cChek Pro Glycohemoglobin Analyzer | 2021-06-02A1cChek Pro Glycohemoglobin Analysis System is intended for the percent determination of Hemoglobin A1c in human whole blood using boronate affinity chromatography. A1cChek Pro Glycohemoglobin Analyzer is intended for Professional Use Only. For In Vitro Diagnostic Use Only. |
| 06935784400026 - BioHermes A1cChek Pro Glycohemoglobin Analyzer | 2021-06-02 A1cChek Pro Glycohemoglobin Analysis System is intended for the percent determination of Hemoglobin A1c in human whole blood usi |