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Device Listing on FDA Website

16 reagents manufactured by Hipro have processed device listing on the FDA website.


No.Name of reagents/instrumentsRegulation NumberRegistered Establishment NumberOwner/Operator Number
1Hipro Antistreptolysin O (ASO) Test Kit866.3720301737920310072388
2Prealbumin Test Kit866.5060301737920310072388
3Retinol-binding protein test kit866.5765301737920310072388
4Alpha-1 Microglobulin test kit866.5400301737920310072388
5Prolactin test kit862.1625301737920310072388
6Beta-2-microglobulin test kit866.5630301737920310072388
7Estradiol test kit862.1260301737920310072388
8Follicle Stimulating Hormone test kit862.1300301737920310072388
9Luteinizing Hormone test kit862.1485301737920310072388
10Progesterone test kit862.1620301737920310072388
11Total Triiodothyronine test kit862.1710301737920310072388
12Total Thyroxine test kit862.1700301737920310072388
13Triglyceride test kit862.1705301737920310072388
14Hipro HDL-C Test Kit862.1475301737920310072388
15Hipro LDL-C test kit862.1475301737920310072388
16Hipro Total Cholesterol test kit862.1175301737920310072388




About FDA & Device Listing

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).


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