SPOTCHECK 80-1000-13

GUDID 00725609000007

Phenylalanine 50 Hour Reagent Kit

ASTORIA-PACIFIC, INC.

Phenylalanine IVD, kit, enzyme fluorescence

• Primary Device ID: 00725609000007
• NIH Device Record Key: cf158dbf-2d4d-4afd-9a13-d44fed9e6aab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPOTCHECK
• Version Model Number: 80-1000-13
• Catalog Number: 80-1000-13
• Company DUNS: 623238615
• Company Name: ASTORIA-PACIFIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00725609000007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K891070

FDA Product Code

• JNB: Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-14

On-Brand Devices [SPOTCHECK]

• 00725609000519: Incubation Bath, 110 Volt
• 00725609000502: Uridyltransferase Blank Cartridge
• 00725609000496: Uridyltransferase Active Cartridge
• 00725609000458: Negative Control Card
• 00725609000441: Positive Controls, Pkg/4
• 00725609000434: NeoPac Software with Manual
• 00725609000427: 307 Detector, 3 Fluorometers
• 00725609000410: 307 Detector, 2 Fluorometers
• 00725609000403: 307 Detector, 1 Fluorometer
• 00725609000397: 315-2 Detector, 110 Volt with Tungsten
• 00725609000380: Uridyltransferase Blank Cartridge
• 00725609000373: Uridyltransferase Active Cartridge
• 00725609000366: Total Galactose + GALT Cartridge
• 00725609000359: Total Galactose Cartridge
• 00725609000342: G6PD Cartridge
• 00725609000335: Biotinidase Cartridge
• 00725609000328: 303A, 4 Heat Bath Cartridge Module
• 00725609000311: 303A, 3 Heat Bath Cartridge Module
• 00725609000304: 303A, 2 Heat Bath Cartridge Module
• 00725609000298: 303 Cartridge Base
• 00725609000281: Micropump 302D-EX,42 Position
• 00725609000274: 302D Micropump, 36 Position
• 00725609000267: SPOTCHECK Pro
• 00725609000250: Biotinidase PABA Stock Standard, 10 x 50 mL
• 00725609000243: Biotinidase System Control, 10 x 50 mL
• 00725609000236: Biotinidase System Control, 50 mL
• 00725609000229: Biotinidase PABA Stock Standard, 50 mL
• 00725609000212: Negative Controls, Pkg/4
• 00725609000205: Positive Control Card
• 00725609000182: UT System Control, 10 x 50 mL
• 00725609000175: UT System Control, 50 mL
• 00725609000168: NADH Stock Standard, 10 x 50 mL
• 00725609000151: NADH Stock Standard, 50 mL
• 00725609000144: Biotinidase Microplate Reagent Kit, 60 Plate
• 00725609000137: Biotinidase Microplate Reagent Kit, 20 Plate
• 00725609000120: GALT Microplate Reagent Kit, 60 Plate
• 00725609000113: GALT Microplate Reagent Kit, 20 Plate
• 00725609000106: Total Galactose Microplate Reagent Kit, 60 Plate
• 00725609000090: Total Galactose Microplate Reagent Kit, 20 Plate
• 00725609000083: Biotinidase 50 Hour Reagent Kit
• 00725609000076: Biotinidase 50 Hour Reagent Kit
• 00725609000069: Uridyltransferase 50 Hour Reagent Kit
• 00725609000052: Uridyltransferase 50 Hour Reagent Kit
• 00725609000045: Uridyltransferase 50 Hour Reagent Kit
• 00725609000038: G6PD 25 Hour Reagent Kit
• 00725609000021: G6PD 50 Hour Reagent Kit
• 00725609000014: Total Galactose 50 Hour Reagent Kit
• 00725609000007: Phenylalanine 50 Hour Reagent Kit
• 00725609000649: T4 Neonatal Screening Kit, 480 Test; An Enzyme Immunoassay (EIA) for the Quantitative Determinat
• 00725609000625: 17-OHP Neonatal Screening Kit, 480 Test; An Enzyme Immunoassay (EIA) for the Quantitative Determ