CRYOcheck™ Lupus Positive Control

GUDID 00843876000152

Precision Biologic Inc

Lupus anticoagulant marker IVD, control
Primary Device ID00843876000152
NIH Device Record Keye3a05f2c-8eb4-4bb5-b0a9-cf518f6cf086
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRYOcheck™ Lupus Positive Control
Version Model NumberCCLP-10
Company DUNS244713368
Company NamePrecision Biologic Inc
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100843876000152 [Primary]
GS100843876010151 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GGNPlasma, Coagulation Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [CRYOcheck™ Lupus Positive Control]

00843876000152CCLP-10
00843876000145CCLP-05

Trademark Results [CRYOcheck]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CRYOCHECK
CRYOCHECK
77260682 3656409 Live/Registered
PRECISION BIOLOGIC INC.
2007-08-21

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