| Primary Device ID | 06935784430016 |
| NIH Device Record Key | 76866856-0cda-4f46-8e09-9db9cb2a5195 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioHermes Automated Glycohemoglobin Analyzer |
| Version Model Number | BH60 |
| Catalog Number | HP-M51 |
| 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 | 06935784430016 [Primary] |
| PDJ | Hemoglobin A1c Test System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-01-12 |
| Device Publish Date | 2022-01-04 |
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| 16935784420250 - 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 |
| 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 | 2022-01-12The BH60 Automated Glycohemoglobin Analyzer is intended for in vitro diagnostic use for the quantitative measurement of HbA1c in whole blood specimens in combination with Glycohemoglobin Analytical Column and Glycohemoglobin Reagent Kit produced by Wuxi Biohermes Bio & Medical Technology Co., Ltd. using ion-exchange high-performance liquid chromatography (HPLC). |
| 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 |
| 06935784400019 - BioHermes A1C EZ 2.0 Glycohemoglobin Analyzer | 2021-06-02 A1C EZ 2.0 Glycohemoglobin Analyzer is intended to be used for testing glycohemoglobin concentration as anaid to monitor the ris |
| 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 |