SPOTCHECK 910-0500-00

GUDID 00725609000267

SPOTCHECK Pro

ASTORIA-PACIFIC, INC.

Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory

• Primary Device ID: 00725609000267
• NIH Device Record Key: 80050ee3-8f87-45e8-ad9f-cb5f643768a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPOTCHECK
• Version Model Number: 910-0500-00
• Catalog Number: 910-0500-00
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	00725609000267 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102643

FDA Product Code

• JJQ: Colorimeter, Photometer, Spectrophotometer For Clinical Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-23
• 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