FDA Registration
Active
🇺🇸 United States
KOVA INTERNATIONAL INC
Reg #: 3010152370
·
FEI: 3010152370
·
Expires 2026
Products
7
Proprietary Names
23
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- KOVA INTERNATIONAL INC
- Registration Number
- 3010152370
- FEI Number
- 3010152370
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7272 Chapman Ave Suite B
- City
- Garden Grove
- State
- CA
- ZIP
- 92841
- Country
- US
Regulatory Submissions
- 510(k) Number
- K843565
Owner / Operator
- Firm Name
- LGC Clinical Diagnostics
- Operator Number
- 10043604
- Address
- 7272 Chapman Ave, Suite B
- City
- Garden Grove
- State
- CA
- Postal Code
- 92841
- Country
- US
- Correspondent
- Gary J Padron
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | Class 1 | Gastroenterology, Urology | No | 2014-01-22 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2016-07-12 |
| Urinalysis Controls (Assayed And Unassayed) | JJW | Class 1 | Clinical Chemistry | No | 2013-03-04 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2013-03-04 |
| Slides, Microscope | KEW | Class 1 | Pathology | No | 2013-03-21 |
| Station, Pipetting And Diluting, For Clinical Use | JQW | Class 1 | Clinical Chemistry | No | 2013-03-21 |
| Crystal Violet For Histology | ICF | Class 1 | Hematology | No | 2013-03-21 |
Proprietary Names
Kova KO-LEC-PAC
KOVA System Value Pac 500
KOVA System Super Pac 1000
KOVA System Pac II
Kova Economy Tube
Kova Super Tube
KOVA Cap
KOVA-poc System Pack
Kova-Trol
Refractrol
Kova Slide II
Kova Slide II with Grid
Kova Fast-Read 102
Kova BVS100H
Kova Glasstic Slide 10
Kova Glasstic Slide 10 with Grid
Kova Petter
Kova Stain
KOVA-poc Dropper Bottle Control Set (10x 5mL)
KOVA-poc Dip-Tube with Microscopics (6x 15mL)
KOVA-poc Dropper Bottle Control Set (2x 5mL)
KOVA-poc Dropper Bottle Control Set (4x 25mL)
Liqua-Trol
Establishment Types
Manufacture Medical Device