| Primary Device ID | 06935784400286 |
| NIH Device Record Key | ff646e50-3c41-460e-b61e-4f5516ee46d8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioHermes Insulin-like Growth Factor Binding Protein-1 & Fetal Fibronectin Kit |
| Version Model Number | COM-S0101E0 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| 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 | 06935784400286 [Primary] |
| GS1 | 16935784400283 [Package] Package: box [25 Units] In Commercial Distribution |
| 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 |
| 06935784400088 - BioHermes Glycohemoglobin Quality Control | 2022-09-05 Glycohemoglobin Quality Control, (10x50uL)/Kit. Intended use: The Glycohemoglobin Quality Control is intended to be used as a |
| 16935784410008 - BioHermes A1C EZ 2.0 Glycohemoglobin Analyzer | 2022-09-05 A1C EZ 2.0 Glycohemoglobin Analyzer is intended to be used for testing glycohemoglobin concentration as anaid to monitor the ris |
| 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 |
| 06935784400286 - BioHermes Insulin-like Growth Factor Binding Protein-1 & Fetal Fibronectin Kit | 2022-01-12Insulin-like Growth Factor Binding Protein-1 & Fetal Fibronectin Kit (Colloidal Gold) 1 Test/Kit lntended use: this combo test kit is used for in vitro diagnostic testing for qualitatively measuring the Insulin-like Growth Factor Binding Proteir-1 (IGFBP-1) and fetal Fibronectin (fFN) levels in the secretions of pregnant women patients. It can work as an auxiliary diagnosis of membrane rupture in pregnant women (including premature rupture of membranes) and also work as a method to predict the pregnancy status in labor (including premature delivery). Contents: 1.one dipstick in a sealed alurminum foil pouch with desiccant; 2.one tube of specimen extraction solution (1.0 ml), this phosphate-bufferedsolution contains preservatives; 3.one instruction for use. |
| 06935784400286 - BioHermes Insulin-like Growth Factor Binding Protein-1 & Fetal Fibronectin Kit | 2022-01-12 Insulin-like Growth Factor Binding Protein-1 & Fetal Fibronectin Kit (Colloidal Gold) 1 Test/Kit lntended use: this combo test |
| 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 |