Test, Methaqualone, Employment and Insurance Testing, Exempt
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Zhejiang and Guangdong: 6 hold an FDA registration. 1 is a contract manufacturer.
- Assure Tech. (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
- Eterbio, Inc. Guangdong
- Hangzhou Lysun Biotechnology Co., Ltd. Zhejiang
- Hangzhou Tongzhou Biotechnology Co., Ltd. Zhejiang
- Hangzhou AllTest Biotech Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Orient Gene Biotech Zhejiang, contract manufacturer
What Is It?
The methaqualone test is an in vitro diagnostic test for the qualitative analysis of methaqualone for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce.
If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing.
What Is FDA Product Code PVF?
Test, Methaqualone, Employment And Insurance Testing, Exempt is FDA product code PVF, Class 2, 21 CFR 862.3630.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.