ASTORIA-PACIFIC, INC.

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

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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) (1) Analyzer, Chemistry, Micro, For Clinical Use (JJF) (1) Enzymatic Methods, Galactose (JIA) (1) Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine (KLI) (1) Multi-Analyte Controls Unassayed (OHQ) (1) Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine (JNB) (1) Radioimmunoassay, 17-Hydroxyprogesterone (JLX) (1) Radioimmunoassay, Thyroid-Stimulating Hormone (JLW) (1)

Premarket Exempt

No Yes

Clear

SPOTCHECK - 00725609000502 Catalog Number : 303-A980-00B

Device Description : Uridyltransferase Blank Cartridge

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JJF

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000519 Catalog Number : 361-A803-00

Device Description : Incubation Bath, 110 Volt

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JJC

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000526 Catalog Number : 82-0200P6K

Device Description : MS/MS Blood Spot Controls; Dried Blood Spots (containing Amino Acids, Free Carni MS/MS Blood Spot Controls; Dried Blood Spots (containing Amino Acids, Free Carnitine, Acylcarnitine, and Succinylacetone) for Quality Control Use with Tandem Mass Spectrometry (MS/MS) Newborn Screening Systems

Device Class : 1

Duns Number: 623238615

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000595 Catalog Number : 81-2500-05K

Device Description : Total Galactose Neonatal Screening Kit, 500 Test; An Enzymatic Colorimetric Assa Total Galactose Neonatal Screening Kit, 500 Test; An Enzymatic Colorimetric Assay for the Quantitative Determination of Total Galactose (Galactose and Galactose-1-Phosphate) Levels in Neonates

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JIA

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000601 Catalog Number : 81-1100-05K

Device Description : Phenylalanine Neonatal Screening Kit, 500 Test; An Enzymatic Colorimetric Assay Phenylalanine Neonatal Screening Kit, 500 Test; An Enzymatic Colorimetric Assay for the Quantitative Determination of Phenylalanine Levels in Neonates

Device Class : 2

Duns Number: 623238615

Premarket Exempt : No

Product Code : JNB

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000618 Catalog Number : 85-1000-05K

Device Description : TSH Neonatal Screening Kit, 480 Test; An Enzyme Immunoassay (EIA) for the Quanti TSH Neonatal Screening Kit, 480 Test; An Enzyme Immunoassay (EIA) for the Quantitative Determination of Thyroid Stimulating Hormone (TSH) Levels in Neonates

Device Class : 2

Duns Number: 623238615

Premarket Exempt : No

Product Code : JLW

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000625 Catalog Number : 85-2000-05K

Device Description : 17-OHP Neonatal Screening Kit, 480 Test; An Enzyme Immunoassay (EIA) for the Qua 17-OHP Neonatal Screening Kit, 480 Test; An Enzyme Immunoassay (EIA) for the Quantitative Determination of 17α-Hydroxyprogesterone (17-OHP) Levels in Neonates

Device Class : 1

Duns Number: 623238615

Premarket Exempt : No

Product Code : JLX

Prescription Use : Yes

Device Count : 1

SPOTCHECK - 00725609000649 Catalog Number : 85-4000-05K

Device Description : T4 Neonatal Screening Kit, 480 Test; An Enzyme Immunoassay (EIA) for the Quantit T4 Neonatal Screening Kit, 480 Test; An Enzyme Immunoassay (EIA) for the Quantitative Determination of Thyroxine (T4) Levels in Neonates

Device Class : 2

Duns Number: 623238615

Premarket Exempt : No

Product Code : KLI

Prescription Use : Yes

Device Count : 1

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