AmplideX Fragile X Dx & Carrier Screen Kit 49591

GUDID 00863840000254

ASURAGEN, INC.

Fragile X syndrome IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00863840000254
• NIH Device Record Key: 04a6fb18-5ac0-4b00-bdd8-770addffa1dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AmplideX Fragile X Dx & Carrier Screen Kit
• Version Model Number: 49591
• Catalog Number: 49591
• Company DUNS: 622988330
• Company Name: ASURAGEN, 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863840000254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN190023

FDA Product Code

• OYV: Inherited Nucleotide Repeat Disorder Dna Test

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-15
• Device Publish Date: 2020-04-07

Devices Manufactured by ASURAGEN, INC.

• 00850017493087 - ROX 1000 Size Ladder: 2023-11-16 General Purpose Reagent
• 00863840000254 - AmplideX Fragile X Dx & Carrier Screen Kit: 2020-04-15
• 00863840000254 - AmplideX Fragile X Dx & Carrier Screen Kit: 2020-04-15
• 00863840000285 - RNARetain: 2019-11-13
• 00863840000223 - QuantideX qPCR BCR-ABL IS Kit: 2019-10-18