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) (10)

Premarket Exempt

Yes No

Clear

KOVA - 00855617006293 Catalog Number : 87327E

Device Description : KOVA-Trol III Normal w/hCG (4x60 mL)

Device Class : 1

Duns Number: 078780990

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

KOVA - 00855617006309 Catalog Number : 87426E

Device Description : KOVA-Trol I: High Abnormal without urobilinogen (8x60 mL)

Device Class : 1

Duns Number: 078780990

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

KOVA - 00855617006316 Catalog Number : 87428E

Device Description : KOVA-Trol II: Low Abnormal (8x60 mL)

Device Class : 1

Duns Number: 078780990

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

KOVA - 00855617006323 Catalog Number : 87528E

Device Description : KOVA-Trol III: Normal with hCG (8x60 mL)

Device Class : 1

Duns Number: 078780990

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

KOVA - 00855617006330 Catalog Number : 87533E

Device Description : KOVA-Trol I: High Abnormal with urobilinogen (8x60 mL)

Device Class : 1

Duns Number: 078780990

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

KOVA - 00855617006347 Catalog Number : 87426

Device Description : High Abnormal without urobilinogen (8x60mL)

Device Class : 1

Duns Number: 078780990

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

KOVA - 00855617006354 Catalog Number : 87426Q

Device Description : High Abnormal without urobilinogen (8x60mL) QUEST

Device Class : 1

Duns Number: 078780990

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

KOVA - 00855617006361 Catalog Number : 87428

Device Description : KOVA-TROL II (8X60mL)

Device Class : 1

Duns Number: 078780990

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

KOVA - 00855617006378 Catalog Number : 87428Q

Device Description : KOVA-Trol II: Low Abnormal (8x60 mL) QUEST

Device Class : 1

Duns Number: 078780990

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

KOVA - 00855617006385 Catalog Number : 87528

Device Description : KOVA-TROL III Normal (8X60mL)

Device Class : 1

Duns Number: 078780990

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

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