FDA Registration
Active
🇨🇳 China
W.H.P.M. Bioresearch & Technology Co., Ltd.
Reg #: 3005345870
·
FEI: 3005345870
·
Expires 2026
Products
37
Proprietary Names
46
Establishment Types
1
Classifications
37
Registration Details
- Registration Name
- W.H.P.M. Bioresearch & Technology Co., Ltd.
- Registration Number
- 3005345870
- FEI Number
- 3005345870
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Building 9, No.9 Tianfu Street, Daxing District
- City
- BEIJING
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K052197
Owner / Operator
- Firm Name
- W.H.P.M. Bioresearch & Technology Co., Ltd.
- Operator Number
- 9076940
- Address
- Building 9, No.9 Tianfu Street,, Daxing District
- City
- BEIJING
- State
- CN-BJ
- Postal Code
- 102629
- Country
- CN
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2007-11-07 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2007-11-07 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2007-11-07 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2007-11-07 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2007-11-07 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2007-11-07 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2017-04-20 |
| Test, Methadone, Employment And Insurance Testing, Exempt | PVE | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2005-08-31 |
| Reagents, Test, Tetrahydrocannabinol | DKE | Class 2 | Clinical Toxicology | No | 2005-08-31 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2005-08-31 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2005-08-31 |
| Reagent, Occult Blood | KHE | Class 2 | Hematology | No | 2005-08-31 |
| Test, Methamphetamine, Employment And Insurance Testing, Exempt | PVD | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Test, Amphetamine, Employment And Insurance Testing, Exempt | PUX | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Test, Opiates, Employment And Insurance Testing, Exempt | PVH | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2013-11-25 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | Class 1 | Clinical Chemistry | No | 2014-12-18 |
| Automated Occult Blood Analyzer | OOX | Class 2 | Hematology | No | 2025-01-13 |
| Fluorometer, For Clinical Use | KHO | Class 1 | Clinical Chemistry | No | 2021-12-15 |
| Test, Benzodiazepine, Employment And Insurance Testing, Exempt | PUZ | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2017-04-20 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2014-04-02 |
| Test, Barbiturate, Employment And Insurance Testing, Exempt | PUY | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2026-04-02 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2026-04-02 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2026-04-02 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2026-04-02 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2026-04-02 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2026-04-02 |
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2026-04-02 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2026-04-02 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2026-04-02 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2026-04-02 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2010-02-08 |
| Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt | PVA | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Test, Cannabinoid, Employment And Insurance Testing, Exempt | PVJ | Class 2 | Clinical Toxicology | No | 2022-05-18 |
Proprietary Names
First Sign Drug of Abuse Screening Test
STAT Dip One Step Drug Test
STAT Cup One Step Drug Test
STAT Cup II One Step Drug Test
STAT Cassette One Step Drug Test
First Sign Drug of Abuse Dip Card Test
First Sign Drug of Abuse Cup Test
FIRST SIGN DRUG OF
One Step Fentanyl Drug of Abuse Test (10 ng/mL)
Pregnancy Test
First Sign Drug of Abuse MDMA Dip Card Test
First Sign Drug of Abuse MDMA Cup Test
First Sign Drug of Abuse EDDP Cup Test
First Sign Drug of Abuse Nortriptyline Cup Test
First Sign Drug of Abuse Nortriptyline Dip Card Test
First Sign Drug of Abuse EDDP Dip Card Test
FSH OTC
Hemosure Accu-Reader A100
Fluorescence Immunoassay Accu Reader
LH Urine Test Strip
Precision DX
Onescreen
ON-Site
Origin
CRLstat
DrugCheck
ECO II
ECO IV
ECO I
EZ CLICK
Precision Plus,
Discover Plus
First Sign
G-Card
Serenity
zerochaos
WH Accu Test One Step Urine/Serum
First Sign Drug of Abuse Buprenorphine Cup Test
First Sign Drug of Abuse Butalbital Cup Test
First Sign Drug of Abuse Morphine Dip Card Test
First Sign Drug of Abuse Morphine Cup Test
First Sign Drug of Abuse Buprenorphine Dip Card Test
First Sign Drug of Abuse Butalbital Dip Card Test
One Strep Pregnancy
WH Accu Test Pregnancy Test
Precision Plus
Establishment Types
Manufacture Medical Device