RNARetain 84001

GUDID 00863840000285

ASURAGEN, INC.

General specimen container IVD, preservation solution, non-sterile General specimen container IVD, preservation solution General specimen container IVD, preservation solution General specimen container IVD, preservation solution General specimen container IVD, preservation solution General specimen container IVD, preservation solution General specimen container IVD, preservation solution General specimen container IVD, preservation solution General specimen container IVD, preservation solution General specimen container IVD, preservation solution General specimen container IVD, preservation solution General specimen container IVD, preservation solution General specimen container IVD, preservation solution General specimen container IVD, preservation solution General specimen container IVD, preservation solution General specimen container IVD, preservation solution General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium

• Primary Device ID: 00863840000285
• NIH Device Record Key: 368271f9-d4bc-4c5d-8fbe-0d2bf65866d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RNARetain
• Version Model Number: 84001
• Catalog Number: 84001
• 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: false
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863840000285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113420

FDA Product Code

• OZF: Tissue Rna Preservative For Collection, Storage, And Transportation

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: 2019-11-13
• Device Publish Date: 2019-11-05

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
• 00863840000285 - RNARetain: 2019-11-13
• 00863840000285 - RNARetain: 2019-11-13
• 00863840000223 - QuantideX qPCR BCR-ABL IS Kit: 2019-10-18