UroMap Specimen Collection Kit UM-00001

GUDID 00860193001761

The UroMap Specimen Collection Kit is intended for the collection and processing of urine specimens for the assessment of the probability of T-cell mediated rejection and BK virus nephropathy in kidney transplant patients. The UroMap Specimen collection kit is not intended for home use and is intended to be used by trained medical personnel.

CAREDX, INC.

Urine specimen collection kit IVD

• Primary Device ID: 00860193001761
• NIH Device Record Key: aecbc896-805e-4aa7-9da1-16724ff6cac8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UroMap Specimen Collection Kit
• Version Model Number: UM-00001
• Catalog Number: UM-00001
• Company DUNS: 102819484
• Company Name: CAREDX, 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 4152872427
• Email: rramirez@caredx.com
• Phone: 4152872427
• Email: rramirez@caredx.com
• Phone: 4152872427
• Email: rramirez@caredx.com
• Phone: 4152872427
• Email: rramirez@caredx.com
• Phone: 4152872427
• Email: rramirez@caredx.com
• Phone: 4152872427
• Email: rramirez@caredx.com
• Phone: 4152872427
• Email: rramirez@caredx.com
• Phone: 4152872427
• Email: rramirez@caredx.com
• Phone: 4152872427
• Email: rramirez@caredx.com
• Phone: 4152872427
• Email: rramirez@caredx.com
• Phone: 4152872427
• Email: rramirez@caredx.com
• Phone: 4152872427
• Email: rramirez@caredx.com
• Phone: 4152872427
• Email: rramirez@caredx.com
• Phone: 4152872427
• Email: rramirez@caredx.com
• Phone: 4152872427
• Email: rramirez@caredx.com
• Phone: 4152872427
• Email: rramirez@caredx.com
• Phone: 4152872427
• Email: rramirez@caredx.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860193001761 [Primary]

FDA Product Code

• OIE: Urine Collection Kit (Excludes Hiv Testing)

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: 2023-02-20
• Device Publish Date: 2023-02-10

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• 00860193001761 - UroMap Specimen Collection Kit: 2023-02-20 The UroMap Specimen Collection Kit is intended for the collection and processing of urine specimens for the assessment of the pr
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