KOVA INTERNATIONAL, INC.

KOVA INTERNATIONAL, INC.

Address:7272 Chapman Ave Suite B,Garden Grove,CA,92841,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Crystal Violet For Histology (ICF) (5) Container, Specimen Mailer And Storage, Non-Sterile (NNK) (3) Slides, Microscope (KEW) (3) Urinalysis Controls (Assayed And Unassayed) (JJW) (1)

Premarket Exempt

No Yes

Clear

KOVA - 00850015517006 Catalog Number : 87154

Device Description : Super-Pac 1000

Device Class : 1

Duns Number: 078780990

Premarket Exempt : Yes

Product Code : KEW, NNK

Prescription Use : No

Device Count : 1

KOVA - 00850015517013 Catalog Number : 87154E

Device Description : Super-Pac 1000International

Device Class : 1

Duns Number: 078780990

Premarket Exempt : Yes

Product Code : KEW, NNK

Prescription Use : No

Device Count : 1

KOVA - 00850015517020 Catalog Number : 84652

Device Description : KOVA Refractrol SP, Low Level

Device Class : 1

Duns Number: 078780990

Premarket Exempt : Yes

Product Code : ICF

Prescription Use : No

Device Count : 1

KOVA - 00850015517037 Catalog Number : 84653

Device Description : KOVA Refractrol SP, Normal Level

Device Class : 1

Duns Number: 078780990

Premarket Exempt : Yes

Product Code : ICF

Prescription Use : No

Device Count : 1

KOVA - 00850015517044 Catalog Number : 84654

Device Description : KOVA Refractrol SP, High Level

Device Class : 1

Duns Number: 078780990

Premarket Exempt : Yes

Product Code : ICF

Prescription Use : No

Device Count : 1

KOVA - 00850015517051 Catalog Number : 84655

Device Description : KOVA Refractrol, High 9.0

Device Class : 1

Duns Number: 078780990

Premarket Exempt : Yes

Product Code : ICF

Prescription Use : No

Device Count : 1

KOVA - 00850015517068 Catalog Number : 84679

Device Description : KOVA Refractrol, Low 6.0

Device Class : 1

Duns Number: 078780990

Premarket Exempt : Yes

Product Code : ICF

Prescription Use : No

Device Count : 1

KOVA - 00850015517075 Catalog Number : 88100

Device Description : KOVA-poc, Urinalysis System Pac

Device Class : 1

Duns Number: 078780990

Premarket Exempt : Yes

Product Code : NNK

Prescription Use : No

Device Count : 1

KOVA - 00850015517082 Catalog Number : 88010

Device Description : FastRead Slides w/grids

Device Class : 1

Duns Number: 078780990

Premarket Exempt : Yes

Product Code : KEW

Prescription Use : No

Device Count : 1

Cardinal Health - 00850015517099 Catalog Number : 89209

Device Description : CARDINAL HEALTH® UA CONTROL TUBE SET, 15mL

Device Class : 1

Duns Number: 078780990

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

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