Accuwell 6020-20-EGAL

GUDID 00725609000199

Total Galactose 2000 Test Kit

ASTORIA-PACIFIC, INC.

Total galactose IVD, kit, enzyme spectrophotometry

• Primary Device ID: 00725609000199
• NIH Device Record Key: f530fa16-a107-4144-b724-2479a14497c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accuwell
• Version Model Number: 6020-20-EGAL
• Catalog Number: 6020-20-EGAL
• 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	00725609000199 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991498

FDA Product Code

• JIA: Enzymatic Methods, Galactose

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

Devices Manufactured by ASTORIA-PACIFIC, INC.

• 00725609000465 - SPOTCHECK: 2020-12-25 MS/MS Positive 2 Control Card
• 00725609000472 - SPOTCHECK: 2020-12-25 MS/MS Positive 1 Control Card
• 00725609000489 - SPOTCHECK: 2020-12-25 MS/MS Negative Control Card
• 00725609000526 - SPOTCHECK: 2020-12-25 MS/MS Blood Spot Controls; Dried Blood Spots (containing Amino Acids, Free Carnitine, Acylcarnitine, and Succinylacetone) for Qu
• 00725609000595 - SPOTCHECK: 2020-12-25 Total Galactose Neonatal Screening Kit, 500 Test; An Enzymatic Colorimetric Assay for the Quantitative Determination of Total Ga
• 00725609000601 - SPOTCHECK: 2020-12-25 Phenylalanine Neonatal Screening Kit, 500 Test; An Enzymatic Colorimetric Assay for the Quantitative Determination of Phenylalan
• 00725609000618 - SPOTCHECK: 2020-12-25 TSH Neonatal Screening Kit, 480 Test; An Enzyme Immunoassay (EIA) for the Quantitative Determination of Thyroid Stimulating Horm
• 00725609000625 - SPOTCHECK: 2020-12-25 17-OHP Neonatal Screening Kit, 480 Test; An Enzyme Immunoassay (EIA) for the Quantitative Determination of 17α-Hydroxyprogester