ASTORIA-PACIFIC, INC.

Address:15130 S.E. 82ND DR.,Clackamas,OR,97015,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

Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use (JJC) (4) Multi-Analyte Controls Unassayed (OHQ) (3) Enzyme Controls (Assayed And Unassayed) (JJT) (2) Analyzer, Chemistry, Micro, For Clinical Use (JJF) (1)

Premarket Exempt

Yes No

Clear

SPOTCHECK - 00725609000403 Catalog Number : 307-A001-01

Device Description : 307 Detector, 1 Fluorometer

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JJC

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000410 Catalog Number : 307-A001-02

Device Description : 307 Detector, 2 Fluorometers

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JJC

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000427 Catalog Number : 307-A001-03

Device Description : 307 Detector, 3 Fluorometers

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JJC

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000434 Catalog Number : 307-C001-00

Device Description : NeoPac Software with Manual

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JJC

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000441 Catalog Number : 80-0900P4K

Device Description : Positive Controls, Pkg/4

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JJT

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000458 Catalog Number : 80-0901-01K

Device Description : Negative Control Card

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JJT

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000465 Catalog Number : 82-0201-01K

Device Description : MS/MS Positive 2 Control Card

Device Class : 1

Duns Number: 623238615

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000472 Catalog Number : 82-0200-01K

Device Description : MS/MS Positive 1 Control Card

Device Class : 1

Duns Number: 623238615

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000489 Catalog Number : 82-0202-01K

Device Description : MS/MS Negative Control Card

Device Class : 1

Duns Number: 623238615

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000496 Catalog Number : 303-A980-00A

Device Description : Uridyltransferase Active Cartridge

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JJF

Prescription Use : Yes

Device Count : 1

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