AlloSure Specimen Collection Kit AS-00002

GUDID 00860193001709

Convenience Kit for Phlebotomy kit of blood sample for AlloSure testing

CAREDX, INC.

Phlebotomy kit
Primary Device ID00860193001709
NIH Device Record Key089ca632-453c-40c0-8326-d1d40b4d9b68
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlloSure Specimen Collection Kit
Version Model NumberAS-00002
Catalog NumberAS-00002
Company DUNS102819484
Company NameCAREDX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone415-287-2427
Emailrramirez@caredx.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *2-30C

Device Identifiers

Device Issuing AgencyDevice ID
GS100860193001709 [Primary]

FDA Product Code

OFZBlood Specimen Collection Kit (Excludes Hiv Testing)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-08
Device Publish Date2020-04-30

Devices Manufactured by CAREDX, INC.

00860193001754 - CareDx2023-08-01 Needle, Vacutainer® Safety-Lok™ Blood Collection Set
00860193001761 - UroMap Specimen Collection Kit2023-02-20 The UroMap Specimen Collection Kit is intended for the collection and processing of urine specimens for the assessment of the pr
00860193001730 - KidneyCare Specimen Collection Kit2022-11-08 Convenience Kit for Specimen Collection Phlebotomy
00860193001747 - KidneyCare Specimen Collection Kit2022-11-08 Convenience mobile phlebotomy sample collection kit
00860193001709 - AlloSure Specimen Collection Kit2020-05-08Convenience Kit for Phlebotomy kit of blood sample for AlloSure testing
00860193001709 - AlloSure Specimen Collection Kit2020-05-08 Convenience Kit for Phlebotomy kit of blood sample for AlloSure testing
00860193001716 - Allomap Specimen Collection Kit2020-05-08 Convenience Kit for Phlebotomy of blood sample for AlloMap testing
00860193001723 - HeartCare Specimen Collection Kit2020-05-08 Convenience Kit for Phlebotomy of blood sample for HeartCare testing

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