W.h.p.m. Bioresearch & Technology Co., Ltd.

Registered establishment in Beijing, China. 37 device types.

Registry build 21.09.26

W.h.p.m. Bioresearch & Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Reagent, Occult Blood, Enzyme Immunoassay, Opiates and 35 other device types. Its earliest product listing with the FDA dates from 2005.

Registration

FDA registration record for W.h.p.m. Bioresearch & Technology Co., Ltd.
Registered name W.H.P.M. Bioresearch & Technology Co., Ltd.
Status Registered
Registration expires 2026
Registration number 3005345870
FEI number 3005345870
Establishment type Manufacturer

Chinese Registration

Chinese company register details for W.h.p.m. Bioresearch & Technology Co., Ltd.
Chinese legal name 万华普曼生物工程有限公司
Source export sales certificate, Beijing medical products administration

Location

Address of W.h.p.m. Bioresearch & Technology Co., Ltd.
City Beijing
Province Beijing
Address Building 9, No.9 Tianfu Street
Postal code 102629
Country China

What It Makes

Device types W.h.p.m. Bioresearch & Technology Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Automated Occult Blood Analyzer Class 2 Hemosure Accu-Reader A100 2025 1
Enzyme Immunoassay, Amphetamine Class 2 First Sign Drug of Abuse Screening Test, STAT Cassette One Step Drug Test, STAT Dip One Step Drug Test, First Sign Drug OF, STAT Cup II One Step Drug Test, STAT Cup One Step Drug Test and 2 more 2005 16
Enzyme Immunoassay, Barbiturate Class 2 First Sign Drug of Abuse Butalbital Cup Test, First Sign Drug of Abuse Buprenorphine Dip Card Test, First Sign Drug of Abuse Butalbital Dip Card Test, First Sign Drug of Abuse Morphine Dip Card Test, First Sign Drug of Abuse Buprenorphine Cup Test, First Sign Drug of Abuse Morphine Cup Test and 5 more 2007 12
Enzyme Immunoassay, Benzodiazepine Class 2 First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test, First Sign Drug of Abuse Screening Test, STAT Cassette One Step Drug Test, STAT Cup One Step Drug Test, STAT Dip One Step Drug Test and 1 more 2007 13
Enzyme Immunoassay, Cannabinoids Class 2 Onescreen, Discover Plus, CRLstat, ON-Site, ECO II, zerochaos and 12 more 2017 18
Enzyme Immunoassay, Cocaine And Cocaine Metabolites Class 2 First Sign Drug of Abuse Screening Test, STAT Cassette One Step Drug Test, STAT Dip One Step Drug Test, First Sign Drug OF, STAT Cup II One Step Drug Test, STAT Cup One Step Drug Test and 2 more 2005 16
Enzyme Immunoassay, Methadone Class 2 First Sign Drug of Abuse Nortriptyline Dip Card Test, First Sign Drug of Abuse EDDP Dip Card Test, First Sign Drug of Abuse EDDP Cup Test, First Sign Drug of Abuse MDMA Cup Test, First Sign Drug of Abuse MDMA Dip Card Test, First Sign Drug of Abuse Nortriptyline Cup Test and 7 more 2007 11
Enzyme Immunoassay, Opiates Class 2 First Sign Drug of Abuse Butalbital Cup Test, First Sign Drug of Abuse Buprenorphine Dip Card Test, First Sign Drug of Abuse Butalbital Dip Card Test, First Sign Drug of Abuse Morphine Dip Card Test, First Sign Drug of Abuse Buprenorphine Cup Test, First Sign Drug of Abuse Morphine Cup Test and 8 more 2005 17
Enzyme Immunoassay, Phencyclidine Class U First Sign Drug of Abuse Screening Test, STAT Cassette One Step Drug Test, STAT Dip One Step Drug Test, First Sign Drug OF, STAT Cup II One Step Drug Test, STAT Cup One Step Drug Test and 18 more 2005 16
Fluorometer, For Clinical Use Class 1 Fluorescence Immunoassay Accu Reader 2021 5
Gas Chromatography, Methamphetamine Class 2 First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test, First Sign Drug of Abuse Nortriptyline Dip Card Test, First Sign Drug of Abuse EDDP Dip Card Test, First Sign Drug of Abuse EDDP Cup Test, First Sign Drug of Abuse MDMA Cup Test and 7 more 2007 10
Kit, Test, Pregnancy, Hcg, Over The Counter Class 2 Pregnancy Test, WH Accu Test One Step Urine/Serum 2013 30
Radioimmunoassay, Tricyclic Antidepressant Drugs Class 2 First Sign Drug of Abuse Nortriptyline Dip Card Test, First Sign Drug of Abuse EDDP Dip Card Test, First Sign Drug of Abuse EDDP Cup Test, First Sign Drug of Abuse MDMA Cup Test, First Sign Drug of Abuse MDMA Dip Card Test, First Sign Drug of Abuse Nortriptyline Cup Test and 5 more 2007 9
Reagent, Occult Blood Class 2 2005 5
Reagents, Test, Tetrahydrocannabinol Class 2 First Sign Drug of Abuse Screening Test, STAT Cassette One Step Drug Test, STAT Dip One Step Drug Test, First Sign Drug OF, STAT Cup II One Step Drug Test, STAT Cup One Step Drug Test 2005 1
Test, Amphetamine, Employment And Insurance Testing, Exempt Class 2 2022 11
Test, Amphetamine, Over The Counter Class 2 Onescreen, Discover Plus, CRLstat, ON-Site, ECO II, zerochaos and 10 more 2026 16
Test, Barbiturate, Employment And Insurance Testing, Exempt Class 2 2022 11
Test, Barbiturate, Over The Counter Class 2 Precision DX, G-Card, ECO I, Origin, ECO IV, DrugCheck and 10 more 2026 16
Test, Benzodiazepine, Employment And Insurance Testing, Exempt Class 2 2022 11
Test, Benzodiazepine, Over The Counter Class 2 Precision DX, G-Card, ECO I, Origin, ECO IV, DrugCheck and 10 more 2026 16
Test, Cannabinoid, Employment And Insurance Testing, Exempt Class 2 2022 12
Test, Cannabinoid, Over The Counter Class 2 Precision DX, G-Card, ECO I, Origin, ECO IV, DrugCheck and 10 more 2026 16
Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt Class 2 2022 12
Test, Cocaine And Cocaine Metabolites, Over The Counter Class 2 Onescreen, Discover Plus, CRLstat, ON-Site, ECO II, zerochaos and 10 more 2026 16
Test, Follicle Stimulating Hormone (Fsh), Over The Counter Class 1 FSH OTC 2014 30
Test, Luteinizing Hormone (Lh), Over The Counter Class 1 LH Urine Test Strip 2014 38
Test, Methadone, Employment And Insurance Testing, Exempt Class 2 2022 11
Test, Methadone, Over The Counter Class 2 Precision DX, G-Card, ECO I, Origin, ECO IV, DrugCheck and 10 more 2026 17
Test, Methamphetamine, Employment And Insurance Testing, Exempt Class 2 2022 13
Test, Methamphetamine, Over The Counter Class 2 Onescreen, Discover Plus, CRLstat, ON-Site, ECO II, zerochaos and 10 more 2026 16
Test, Opiates, Employment And Insurance Testing, Exempt Class 2 One Step Fentanyl Drug of Abuse Test (10 ng/mL) 2022 12
Test, Opiates, Over The Counter Class 2 Precision DX, G-Card, ECO I, Origin, ECO IV, DrugCheck and 10 more 2026 18
Test, Propoxyphene, Over The Counter Class 2 Precision DX, G-Card, ECO I, Origin, ECO IV, DrugCheck and 10 more 2026 16
Test, Tricyclic Antidepressants, Over The Counter Class 2 Precision DX, G-Card, ECO I, Origin, ECO IV, DrugCheck and 10 more 2026 16
Thin Layer Chromatography, Methamphetamine Class 2 First Sign Drug of Abuse Screening Test, STAT Cassette One Step Drug Test, STAT Dip One Step Drug Test, First Sign Drug OF, STAT Cup II One Step Drug Test, STAT Cup One Step Drug Test 2005 12
Visual, Pregnancy Hcg, Prescription Use Class 2 One Strep Pregnancy, WH Accu Test Pregnancy Test 2010 16

Clearances

No clearance names W.h.p.m. Bioresearch & Technology Co., Ltd. as applicant. 15 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming W.h.p.m. Bioresearch & Technology Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K200754 2022-06-02 OOX Traditional W.h.p.m., Inc.
K210327 2021-08-12 QBF Traditional W.h.p.m., Inc.
K171695 2018-02-05 NFT Traditional W.h.p.m., Inc.
K160793 2016-08-17 DJR Traditional W.h.p.m., Inc.
K152551 2015-11-09 DJG Traditional W.h.p.m., Inc.
K151441 2015-06-29 DJR Traditional W.h.p.m., Inc.
K150162 2015-02-26 LAF Traditional W.h.p.m., Inc.
K142353 2014-10-07 DIO Traditional W.h.p.m., Inc.
K052197 2006-06-09 DJR Traditional W.h.p.m., Inc.
K051841 2005-08-22 JHI Traditional W.h.p.m., Inc.
K041202 2004-08-12 KHE Traditional W.h.p.m., Inc.
K041273 2004-05-20 LCX Traditional W.h.p.m., Inc.
K032575 2004-05-19 DKZ Traditional W.h.p.m., Inc.
K031271 2003-06-17 LCX Traditional Amerisource Pharmacal, Inc.
K012284 2001-08-28 JHI Traditional W.h.p.m., Inc.

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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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer