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

Urinalysis Controls (Assayed And Unassayed) (JJW) (6) Container, Specimen Mailer And Storage, Non-Sterile (NNK) (3) Crystal Violet For Histology (ICF) (1)

Premarket Exempt

No Yes

Clear

Siemens - 00850015517211 Catalog Number : 11561694

Device Description : UA Diptube Liquid QC

Device Class : 1

Duns Number: 078780990

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

KOVA - 00855617006002 Catalog Number : 87112E

Device Description : Level I Abnormal and Level II Normal with hCG

Device Class : 1

Duns Number: 078780990

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

KOVA - 00855617006019 Catalog Number : 87122E

Device Description : Level II (Normal) w/hCG and Microscopics

Device Class : 1

Duns Number: 078780990

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

KOVA - 00855617006026 Catalog Number : 87176E

Device Description : KOVA Liqua-Trol Level I (Abnormal) w/ microscopics

Device Class : 1

Duns Number: 078780990

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

KOVA - 00855617006033 Catalog Number : 87123E

Device Description : Level II (Normal) w/hCG and microscopics

Device Class : 1

Duns Number: 078780990

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

KOVA - 00855617006040 Catalog Number : 87177E

Device Description : Level I (Abnormal) w/ microscopics

Device Class : 1

Duns Number: 078780990

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

KOVA - 00855617006057 Catalog Number : 87116E

Device Description : KOVA Stain

Device Class : 1

Duns Number: 078780990

Premarket Exempt : Yes

Product Code : ICF

Prescription Use : No

Device Count : 1

KOVA - 00855617006064 Catalog Number : 87153E

Device Description : Super Pac 1000 and Caps

Device Class : 1

Duns Number: 078780990

Premarket Exempt : Yes

Product Code : NNK

Prescription Use : No

Device Count : 1

KOVA - 00855617006071 Catalog Number : 87162E

Device Description : Super Pac 1000

Device Class : 1

Duns Number: 078780990

Premarket Exempt : Yes

Product Code : NNK

Prescription Use : No

Device Count : 1

KOVA - 00855617006088 Catalog Number : 87155E

Device Description : Pac II

Device Class : 1

Duns Number: 078780990

Premarket Exempt : Yes

Product Code : NNK

Prescription Use : No

Device Count : 1

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