FDA Registration
Active
🇺🇸 United States
KEVA INC.
Reg #: 3043196750
·
FEI: 3043196750
·
Expires 2026
Products
26
Proprietary Names
31
Establishment Types
2
Classifications
26
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Registration Details
- Registration Name
- KEVA INC.
- Registration Number
- 3043196750
- FEI Number
- 3043196750
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2794 Peace Portal Dr Unit 130
- City
- Blaine
- State
- WA
- ZIP
- 98230
- Country
- US
Owner / Operator
- Firm Name
- Keva Inc.
- Operator Number
- 10094570
- Address
- 2794 PEACE PORTAL DR UNIT 130
- City
- Blaine
- State
- WA
- Postal Code
- 98230
- Country
- US
- Correspondent
- Saying Mo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Antigens, Cf, All, Mycoplasma Spp. | GSB | Class 1 | Microbiology | No | 2026-02-26 |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | Class U | Unknown | No | 2026-02-26 |
| Antigens, Ha (Including Ha Control), Adenovirus 1-33 | GOB | Class 1 | Microbiology | No | 2026-03-02 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2026-02-26 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2026-02-26 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2026-06-05 |
| Test, Morphine, Over The Counter | NGI | Class 2 | Clinical Toxicology | No | 2026-02-26 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2026-03-23 |
| Antigens, All Groups, Streptococcus Spp. | GTY | Class 1 | Microbiology | No | 2026-02-26 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | Class 1 | Clinical Chemistry | No | 2026-03-02 |
| Legionella, Spp., Elisa | MJH | Class 2 | Microbiology | No | 2026-02-26 |
| Antigen, Cf, Psittacosis (Chlamydia Group) | GPW | Class 1 | Microbiology | No | 2026-02-26 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2026-02-26 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2026-02-26 |
| Devices Detecting Influenza A, B, And C Virus Antigens | PSZ | Class 2 | Microbiology | No | 2026-02-26 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2026-03-02 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2026-03-02 |
| Antisera, All Groups, Salmonella Spp. | GRM | Class 2 | Microbiology | No | 2026-02-26 |
| Helicobacter Pylori | LYR | Class 1 | Microbiology | No | 2026-02-26 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2026-02-26 |
| Enzyme Linked Immunosorbent Assay, T. Cruzi | MIU | Class 1 | Microbiology | No | 2026-03-02 |
| Reagents, Test, Tetrahydrocannabinol | DKE | Class 2 | Clinical Toxicology | No | 2026-02-26 |
| Reagent, Occult Blood | KHE | Class 2 | Hematology | No | 2026-03-02 |
| Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | GQG | Class 1 | Microbiology | No | 2026-02-26 |
| Semen Analysis Device | POV | Class 2 | Hematology | No | 2026-02-26 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2026-03-02 |
Proprietary Names
MYCOPLASMA PNEUMONIAE TEST
PHENCYCLIDINE TEST
ADENOVIRUS ANTIGEN RAPID TEST
ROTAVIRUS ANTIGEN RAPID TEST
METHADONE TEST
COCAINE TEST
LH Ovulation Test
MORPHINE TEST
Human Chorionic Gonadotropin (HCG) Test Kit
GROUP A STREPTOCOCCUS TEST
FOLLICLE-STIMULATING HORMONE TEST
Legionella Antigen Test
CHLAMYDIA TRACHOMATIS TEST
METHAMPHETAMINE TEST
AMPHETAMINE TEST
INFLUENZA A AND B TEST
FENTANYL TEST
OXYCODONE TEST
KETAMINE TEST
SALMONELLA TYPHI/PARA TYPHI ANTIGEN TEST
HELICOBACTER PYLORI ANTIBODY TEST
HELICOBACTER PYLORI ANTIGEN TEST
OPIATES TEST
CHAGAS ANTIBODY TEST
SYNTHETIC MARIJUANA TEST
TETRAHYDROCANNABINOL TEST (CANNABIS METABOLITES)
FECAL OCCULT BLOOD TEST
RESPIRATORY SYNCYTIAL VIRAL ANTIGEN TEST
LUTEINIZING HORMONE TEST
SPERM OK MALE FERTILITY SPERM TEST
METHYLENEDIOXYMETHAMPHETAMINE TEST
Establishment Types
Manufacture Device in the United States for Export Only
Manufacture Medical Device for Another Party (Contract Manufacturer)