SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT
ASTORIA-PACIFIC,INC.
ASTORIA-PACIFIC, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3050015 | 3050015 | ASTORIA-PACIFIC, INC. | 1 | N | 2026-01-01 | 15130 S.E. 82ND DR. Clackamas OR US 97015 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 72959 | 1159247595 | K991498 | ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL | JIA | 1999-06-16 |
| 72959 | 2017535821 | K990957 | ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K | JBL | 1999-05-11 |
| 72959 | 1283384859 | K974047 | ACCUWELL PHENYLALANINE ASSAY | JNB | 1997-12-05 |
| 72959 | 1497926644 | K972974 | ACCUWELL T4-EIA | KLI | 1997-10-06 |
| 72959 | 1405267762 | K970277 | URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) | KQP | 1997-12-11 |
| 72959 | 1959988411 | K970093 | TYROSINE 50-HOUR REAGENT KIT | CDR | 1998-03-19 |
| 72959 | 2046911671 | K894011 | TOTAL GALACTOSE | KQP | 1990-01-11 |
| 72959 | 1113264517 | K891070 | PHENYLALANINE (NINHYDRIN REACTION) | JNB | 1989-10-27 |
| 72959 | 1966938505 | K890332 | RFA/2 RAPID FLOW ANALYZER W/COMPUTER | JJC | 1989-02-17 |
| 72959 | 1804815245 | K883020 | RFA-300 RAPID FLOW ANALYZER W/COMPUTER | JJF | 1988-09-02 |
| 72959 | 1660416320 | K851542 | RFA-300 RAPID FLOW ANALYZER W/COMPUTER | JJF | 1985-05-10 |
| 72959 | 1184277551 | K182141 | |||
| 72959 | 1665949993 | K121101 | SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT | JIA | 2013-06-20 |
| 72959 | 1683401545 | K102643 | SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT | KQP | 2011-07-15 |
| 72959 | 1844412241 | K101392 | NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D | KQP | 2011-02-04 |
| 72959 | 1122149666 | K090940 | SPOTCHECK BLOOD SPOT CONTROL, ASSAYED | JJT | 2009-12-14 |
| 72959 | 1262017239 | K080294 | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT | NAK | 2008-11-04 |
| 72959 | 1505101623 | K060452 | ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH | JLX | 2007-03-13 |
| 72959 | 1671925574 | K010844 | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K | NAK | 2001-09-21 |
| 72959 | 1690438791 | K001455 | ACCUWELL TSH, MODEL KAW-TSH-960 | JLW | 2000-11-02 |
| 72959 | 1525348155 |
Product Codes Associated With Registrations#
PMN#
SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT
ASTORIA-PACIFIC,INC.
NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D
ASTORIA-PACIFIC,INC.
SPOTCHECK BLOOD SPOT CONTROL, ASSAYED
ASTORIA-PACIFIC,INC.
ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT
ASTORIA-PACIFIC,INC.
ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K
ASTORIA-PACIFIC,INC.
ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K
ASTORIA-PACIFIC,INC.
TYROSINE 50-HOUR REAGENT KIT
ASTORIA-PACIFIC,INC.
URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)
ASTORIA-PACIFIC,INC.
GUDID#
SPOTCHECK - 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
2020-12-17
SPOTCHECK - Biotinidase 50 Hour Reagent Kit
2016-10-14
SPOTCHECK - Biotinidase 50 Hour Reagent Kit
2016-10-14
SPOTCHECK - Total Galactose Microplate Reagent Kit, 20 Plate
2016-10-14
SPOTCHECK - Total Galactose Microplate Reagent Kit, 60 Plate
2016-10-14
SPOTCHECK - GALT Microplate Reagent Kit, 20 Plate
2016-10-14
SPOTCHECK - GALT Microplate Reagent Kit, 60 Plate
2016-10-14
SPOTCHECK - Biotinidase Microplate Reagent Kit, 20 Plate
2016-10-14
SPOTCHECK - Biotinidase Microplate Reagent Kit, 60 Plate
2016-10-14
Accuwell - Total Galactose 2000 Test Kit
2016-10-14
SPOTCHECK - Positive Control Card
2016-10-14
SPOTCHECK - Negative Controls, Pkg/4
2016-10-14
SPOTCHECK - SPOTCHECK Pro
2016-10-14
SPOTCHECK - Positive Controls, Pkg/4
2016-10-14
SPOTCHECK - Negative Control Card
2016-10-14
SPOTCHECK - 302D Micropump, 36 Position
2016-10-14
SPOTCHECK - Micropump 302D-EX,42 Position
2016-10-14
SPOTCHECK - 303 Cartridge Base
2016-10-14
SPOTCHECK - 303A, 2 Heat Bath Cartridge Module
2016-10-14
SPOTCHECK - 303A, 3 Heat Bath Cartridge Module
2016-10-14
SPOTCHECK - 303A, 4 Heat Bath Cartridge Module
2016-10-14
SPOTCHECK - Biotinidase Cartridge
2016-10-14
SPOTCHECK - G6PD Cartridge
2016-10-14
SPOTCHECK - Total Galactose Cartridge
2016-10-14
SPOTCHECK - Total Galactose + GALT Cartridge
2016-10-14
SPOTCHECK - Uridyltransferase Active Cartridge
2016-10-14
SPOTCHECK - Uridyltransferase Blank Cartridge
2016-10-14
SPOTCHECK - 315-2 Detector, 110 Volt with Tungsten
2016-10-14
SPOTCHECK - 307 Detector, 1 Fluorometer
2016-10-14
SPOTCHECK - 307 Detector, 2 Fluorometers
2016-10-14
SPOTCHECK - 307 Detector, 3 Fluorometers
2016-10-14
SPOTCHECK - Uridyltransferase Active Cartridge
2016-10-14
SPOTCHECK - Uridyltransferase Blank Cartridge
2016-10-14
SPOTCHECK - Incubation Bath, 110 Volt
2016-10-14
SPOTCHECK - NeoPac Software with Manual
2016-10-14
SPOTCHECK - MS/MS Positive 2 Control Card
2020-12-17
SPOTCHECK - MS/MS Positive 1 Control Card
2020-12-17
SPOTCHECK - MS/MS Negative Control Card
2020-12-17
SPOTCHECK - 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
2020-12-17
SPOTCHECK - Phenylalanine Neonatal Screening Kit, 500 Test; An Enzymatic Colorimetric Assay for the Quantitative Determination of Phenylalanine Levels in Neonates
2020-12-17