CLINIQA CORPORATION

Address:495 Enterprise Street,San Marcos,CA,92078,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

Multi-Analyte Controls, All Kinds (Assayed) (JJY) (8) Urinalysis Controls (Assayed And Unassayed) (JJW) (2)

Premarket Exempt

No Yes

Clear

Immunoassay Control Level 1 - 00817238010400 Catalog Number :

Device Description : Immunoassay Control Level 1

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Immunoassay Control Level 2 - 00817238010417 Catalog Number :

Device Description : Immunoassay Control Level 2

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Immunoassay Control Level 3 - 00817238010424 Catalog Number :

Device Description : Immunoassay Control Level 3

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Liquid QC Immunoassay Control Tri-Level - 00817238010431 Catalog Number :

Device Description : Liquid QC Immunoassay Control Tri-Level

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Tri-Level Immunoassay Control Minipack - 00817238010448 Catalog Number :

Device Description : Tri-Level Immunoassay Control Minipack

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Alcohol/Ammonia Control level 1 - 00817238010455 Catalog Number :

Device Description : Alcohol/Ammonia Control level 1

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Alcohol/Ammonia Control level 2 - 00817238010462 Catalog Number :

Device Description : Alcohol/Ammonia Control level 2

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Alcohol/Ammonia Control Bi-level - 00817238010479 Catalog Number :

Device Description : Alcohol/Ammonia Control Bi-level

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

DipStrip Urinalysis Control Bi-Level - 00817238010486 Catalog Number :

Device Description : DipStrip Urinalysis Control Bi-Level

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

DropStrip Urinalysis Control Bi-Level - 00817238010493 Catalog Number :

Device Description : DropStrip Urinalysis Control Bi-Level

Device Class : 1

Duns Number: 078742335

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

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