KidneyCare Specimen Collection Kit AS-00005

GUDID 00860193001747

Phlebotomy kit Phlebotomy kit Phlebotomy kit Phlebotomy kit Phlebotomy kit

Primary Device ID	00860193001747
NIH Device Record Key	b8ba872e-7a8f-4dee-89f9-1d93594bd6cc
Commercial Distribution Status	In Commercial Distribution
Brand Name	KidneyCare Specimen Collection Kit
Version Model Number	AS-00005
Catalog Number	AS-00005
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	false
RX Perscription	true
OTC Over-The-Counter	false

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 Issuing Agency	Device ID
GS1	00860193001747 [Primary]

OFZ	Blood Specimen Collection Kit (Excludes Hiv Testing)

Steralize Prior To Use	false
Device Is Sterile	false

00860193001747	Convenience mobile phlebotomy sample collection kit
00860193001730	Convenience Kit for Specimen Collection Phlebotomy