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

System,Test,Biotinidase (NAK) (4) Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use (JJC) (3) Enzyme Controls (Assayed And Unassayed) (JJT) (2) Colorimeter, Photometer, Spectrophotometer For Clinical Use (JJQ) (1)

Premarket Exempt

No Yes

Clear

SPOTCHECK - 00725609000205 Catalog Number : 80-0900-01K

Device Description : Positive Control Card

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JJT

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000212 Catalog Number : 80-0901P4K

Device Description : Negative Controls, Pkg/4

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JJT

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000229 Catalog Number : 80-8060-75K

Device Description : Biotinidase PABA Stock Standard, 50 mL

Device Class : 2

Duns Number: 623238615

Premarket Exempt : No

Product Code : NAK

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000236 Catalog Number : 80-8065-75K

Device Description : Biotinidase System Control, 50 mL

Device Class : 2

Duns Number: 623238615

Premarket Exempt : No

Product Code : NAK

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000243 Catalog Number : 80-8065P10K

Device Description : Biotinidase System Control, 10 x 50 mL

Device Class : 2

Duns Number: 623238615

Premarket Exempt : No

Product Code : NAK

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000250 Catalog Number : 80-8060P10K

Device Description : Biotinidase PABA Stock Standard, 10 x 50 mL

Device Class : 2

Duns Number: 623238615

Premarket Exempt : No

Product Code : NAK

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000267 Catalog Number : 910-0500-00

Device Description : SPOTCHECK Pro

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JJQ

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000274 Catalog Number : 302-A100-03

Device Description : 302D Micropump, 36 Position

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JJC

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000281 Catalog Number : 302-A100-03EX

Device Description : Micropump 302D-EX,42 Position

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JJC

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000298 Catalog Number : 303-A000-03

Device Description : 303 Cartridge Base

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JJC

Prescription Use : Yes

Device Count : 1

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