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

Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase (KQP) (4) Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative (JBL) (2) System,Test,Biotinidase (NAK) (2) Enzymatic Methods, Galactose (JIA) (1) Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine (JNB) (1)

Premarket Exempt

No Yes

Clear

SPOTCHECK - 00725609000007 Catalog Number : 80-1000-13

Device Description : Phenylalanine 50 Hour Reagent Kit

Device Class : 2

Duns Number: 623238615

Premarket Exempt : No

Product Code : JNB

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000014 Catalog Number : 80-2000-13K

Device Description : Total Galactose 50 Hour Reagent Kit

Device Class : 2

Duns Number: 623238615

Premarket Exempt : No

Product Code : KQP

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000021 Catalog Number : 80-3000-13K

Device Description : G6PD 50 Hour Reagent Kit

Device Class : 2

Duns Number: 623238615

Premarket Exempt : No

Product Code : JBL

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000038 Catalog Number : 80-3500-13K

Device Description : G6PD 25 Hour Reagent Kit

Device Class : 2

Duns Number: 623238615

Premarket Exempt : No

Product Code : JBL

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000045 Catalog Number : 80-4000-13K

Device Description : Uridyltransferase 50 Hour Reagent Kit

Device Class : 2

Duns Number: 623238615

Premarket Exempt : No

Product Code : KQP

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000052 Catalog Number : 80-4000-CA

Device Description : Uridyltransferase 50 Hour Reagent Kit

Device Class : 2

Duns Number: 623238615

Premarket Exempt : No

Product Code : KQP

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000069 Catalog Number : 80-4500-13K

Device Description : Uridyltransferase 50 Hour Reagent Kit

Device Class : 2

Duns Number: 623238615

Premarket Exempt : No

Product Code : KQP

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000076 Catalog Number : 80-8000-13K

Device Description : Biotinidase 50 Hour Reagent Kit

Device Class : 2

Duns Number: 623238615

Premarket Exempt : No

Product Code : NAK

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000083 Catalog Number : 80-8000-CA

Device Description : Biotinidase 50 Hour Reagent Kit

Device Class : 2

Duns Number: 623238615

Premarket Exempt : No

Product Code : NAK

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000090 Catalog Number : 81-2000-20K

Device Description : Total Galactose Microplate Reagent Kit, 20 Plate

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JIA

Prescription Use : Yes

Device Count : 1

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