16 reagents manufactured by Hipro have processed device listing on the FDA website.
| No. | Name of reagents/instruments | Regulation Number | Registered Establishment Number | Owner/Operator Number |
| 1 | Hipro Antistreptolysin O (ASO) Test Kit | 866.3720 | 3017379203 | 10072388 |
| 2 | Prealbumin Test Kit | 866.5060 | 3017379203 | 10072388 |
| 3 | Retinol-binding protein test kit | 866.5765 | 3017379203 | 10072388 |
| 4 | Alpha-1 Microglobulin test kit | 866.5400 | 3017379203 | 10072388 |
| 5 | Prolactin test kit | 862.1625 | 3017379203 | 10072388 |
| 6 | Beta-2-microglobulin test kit | 866.5630 | 3017379203 | 10072388 |
| 7 | Estradiol test kit | 862.1260 | 3017379203 | 10072388 |
| 8 | Follicle Stimulating Hormone test kit | 862.1300 | 3017379203 | 10072388 |
| 9 | Luteinizing Hormone test kit | 862.1485 | 3017379203 | 10072388 |
| 10 | Progesterone test kit | 862.1620 | 3017379203 | 10072388 |
| 11 | Total Triiodothyronine test kit | 862.1710 | 3017379203 | 10072388 |
| 12 | Total Thyroxine test kit | 862.1700 | 3017379203 | 10072388 |
| 13 | Triglyceride test kit | 862.1705 | 3017379203 | 10072388 |
| 14 | Hipro HDL-C Test Kit | 862.1475 | 3017379203 | 10072388 |
| 15 | Hipro LDL-C test kit | 862.1475 | 3017379203 | 10072388 |
| 16 | Hipro Total Cholesterol test kit | 862.1175 | 3017379203 | 10072388 |
The Food and Drug Administration is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of food supply, cosmetics, and products that emit radiation in the United States.
Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA.
Registration and listing provide the FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation's ability to prepare for and respond to public health emergencies.
Link of Device Listing for 16 medical reagents manufactured by Hipro on FDA website:
Establishment Registration & Device Listing (fda.gov).
