ROX 1000 Size Ladder A00058

GUDID 00850017493087

General Purpose Reagent

ASURAGEN, INC.

Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control

• Primary Device ID: 00850017493087
• NIH Device Record Key: 9dfec55a-c324-418b-97c8-3beea10a33ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROX 1000 Size Ladder
• Version Model Number: A00058
• Catalog Number: A00058
• Company DUNS: 622988330
• Company Name: ASURAGEN, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850017493087 [Primary]

FDA Product Code

• PPM: General Purpose Reagent

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: 2023-11-16
• Device Publish Date: 2023-11-08

Devices Manufactured by ASURAGEN, INC.

• 00850017493087 - ROX 1000 Size Ladder: 2023-11-16General Purpose Reagent
• 00850017493087 - ROX 1000 Size Ladder: 2023-11-16 General Purpose Reagent
• 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