Human Metabolomics Institute, Inc.
Registered establishment in Shenzhen, Guangdong, China. 4 device types.
Human Metabolomics Institute, Inc. is a manufacturer holding a current FDA establishment registration. The registration covers Data Acquisition Software, N-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin and 2 other device types. Its earliest product listing with the FDA dates from 2019.
Registration
| Registered name | HUMAN METABOLOMICS INSTITUTE, INC. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015972771 |
| FEI number | 3015972771 |
| Establishment type | Manufacturer |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Suite 501D1, Building E, Gangzhilong Science and Technology Park, No.6 Qinglong Road, Qinghua Community |
| Postal code | 518109 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | Class 1 | Monoconjugated Bilirubin Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry) | 2021 | 12 |
| Data Acquisition Software | Class 2 | Chronic Liver Disease Risk Assessment Software, Type 2 Diabetes Risk Assessment Software, Liver Steatosis Risk Assessment Software, Liver Fibrosis and Cirrhosis Risk Assessment Software | 2019 | 1 |
| N-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin | Class 1 | L-Tyrosine and Taurocholic Acid Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry), Amino Acid Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry) | 2019 | 2 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | Class 1 | 25-OH Vitamin D Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry) | 2021 | 12 |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Q300 metabolite assay kit, Liver fibrosis screening kit, Diabetes screening kit, Colorectal cancer screening kit, LiveBoost software |
|---|---|
| Certifications | ISO 13485, GMP, 51 Class I medical devices approved, 8 Class II medical devices approved |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.