FDA Registration
Active
🇺🇸 United States
ARK DIAGNOSTICS INC
Reg #: 3005755244
·
FEI: 3005755244
·
Expires 2026
Products
19
Proprietary Names
89
Establishment Types
2
Classifications
19
Registration Details
- Registration Name
- ARK DIAGNOSTICS INC
- Registration Number
- 3005755244
- FEI Number
- 3005755244
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 48089 Fremont Blvd
- City
- Fremont
- State
- CA
- ZIP
- 94538
- Country
- US
Regulatory Submissions
- 510(k) Number
- K182779
Owner / Operator
- Firm Name
- ARK Diagnostics Inc
- Operator Number
- 10027663
- Address
- 48089 Fremont Blvd
- City
- Fremont
- State
- CA
- Postal Code
- 94538
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2019-01-16 |
| Immunoassay, Anti-Seizure Drug | NWM | Class 2 | Clinical Toxicology | No | 2021-09-01 |
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2009-04-30 |
| Drug Specific Control Materials | LAS | Class 1 | Clinical Toxicology | No | 2009-04-30 |
| Test Reagents For Ethyl Alcohol | DMJ | Class 2 | Clinical Toxicology | No | 2017-11-21 |
| Test, Opiates, Employment And Insurance Testing, Exempt | PVH | Class 2 | Clinical Toxicology | No | 2018-04-11 |
| Levetiracetam Assay | ORI | Class 2 | Clinical Toxicology | No | 2024-07-10 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2024-07-23 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2019-06-17 |
| Radioimmunoassay, Vancomycin | LEH | Class 2 | Clinical Toxicology | No | 2018-05-23 |
| Gabapentin Assay | OTF | Class 2 | Clinical Toxicology | No | 2010-11-30 |
| Enzyme Immunoassay, Gentamicin | LCD | Class 2 | Clinical Toxicology | No | 2014-08-26 |
| Test, Benzodiazepine, Employment And Insurance Testing, Exempt | PUZ | Class 2 | Clinical Toxicology | No | 2023-11-14 |
| Enzyme Immunoassay, Oxcarbazepine Metabolite | POX | Class 2 | Clinical Toxicology | No | 2016-08-18 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2018-06-01 |
| Voriconazole Test System | PUJ | Class 2 | Clinical Toxicology | No | 2017-05-09 |
| Lamotrigine Assay | ORH | Class 2 | Clinical Toxicology | No | 2010-11-05 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2019-06-17 |
| Enzyme Immunoassay, Methotrexate | LAO | Class U | Unknown | No | 2024-07-10 |
Proprietary Names
ARK EDDP Control
ARK EDDP Calibrator
ARK EDDP Assay
ARK Lacosamide Assay; ARK Lacosamide Calibrator; ARK Lacosamide Control
ARK Topiramate Control
ARK Topiramate Assay
ARK Topiramate Calibrator
ARK Zonisamide Calibrator
ARK Zonisamide Control
ARK Zonisamide Assay
ARK Ethyl Glucuronide II Assay
ARK Ethyl Glucuronide Calibrator
ARK Ethyl Glucuronide Assay
ARK Ethyl Glucuronide Control
ARK Fentanyl 0.5 ng/mL Assay/Calibrator/Control
ARK Fentanyl II 0.5 ng/mL Assay
ARK Levetiracetam II Assay
ARK Levetiracetam II Control
ARK Levetiracetam II Calibrator
ARK Hydrocodone Control
ARK Hydrocodone Calibrator
ARK Hydrocodone Assay
ARK Ketamine Control
ARK Ketamine Calibrator
ARK Ketamine Assay
ARK Ketamine II Assay
ARK Ketamine II Control
ARK Ketamine II Calibrator
ARK Linezolid Assay
ARK Linezolid Calibrator
ARK Linezolid Control
ARK Gabapentin Calibrator
ARK Gabapentin Assay
ARK Gabapentin Control
ARK Efavirenz Assay
ARK Efavirenz Control
ARK Efavirenz Calibrator
ARK Meperidine Calibrator
ARK Meperidine Control
ARK Meperidine Assay
ARK HS Benzodiazepine II Control
ARK HS Benzodiazepine II Calibrator
ARK HS Benzodiazepine II Assay
ARK Levetiracetam Control
ARK Levetiracetam Calibrator
ARK Levetiracetam Assay
ARK Oxcarbazepine Metabolite Assay
ARK Oxcarbazepine Metabolite Control
ARK Oxcarbazepine Metabolite Calibrator
ARK Pregabalin Urine Control
ARK Pregabalin Urine Assay
ARK Pregabalin Urine Calibrator
ARK Lacosamide Calibrator
ARK Lacosamide Assay
ARK Lacosamide Control
ARK Pregabalin II Calibrator
ARK Pregabalin II Control
ARK Pregabalin II Assay
ARK Methylphenidate Metabolite Calibrator
ARK Methylphenidate Metabolite Assay
ARK Methylphenidate Metabolite Control
ARK Voriconazole II Calibrator
ARK Voriconazole II Assay
ARK Voriconazole II Control
DRI Fentanyl II Assay; DRI Fentanyl II Calibrator; DRI Fentanyl II Control;
ARK Fentanyl II Assay; ARK Fentanyl Calibrator; ARK Fentanyl Control
ARK Lamotrigine Control
ARK Lamotrigine Calibrator
ARK Lamotrigine Assay
ARK Tramadol Assay
ARK Tramadol Control
ARK Tramadol Calibrator
DRI Tramadol Assay
DRI Tramadol Calibrator
DRI Tramadol Control
ARK UR-144/JWH-018 Assay
ARK UR-144/JWH-018 Control
ARK AB-PINACA Control
ARK UR-144/JWH-018 Calibrator
ARK AB-PINACA Assay
ARK AB-PINACA Calibrator
ARK Methotrexate II Calibrator
ARK Methotrexate II Control
ARK Methotrexate II Assay
ARK Methotrexate II Dilution Buffer
ARK Methotrexate Assay
ARK Methotrexate Calibrator
ARK Methotrexate Dilution Buffer
ARK Methotrexate Control
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only