CRYOcheck™ Abnormal 2 Control 00843876010113

GUDID 00843876000114

Precision Biologic Inc

Prothrombin time (PT) IVD, control
Primary Device ID00843876000114
NIH Device Record Keyca4653e5-aa37-40a9-9461-93331ef74972
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRYOcheck™ Abnormal 2 Control
Version Model NumberCCA2-10
Catalog Number00843876010113
Company DUNS244713368
Company NamePrecision Biologic Inc
Device Count80
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
GS100843876000114 [Primary]
GS100843876010113 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GGCControl, Plasma, Abnormal

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

Devices Manufactured by Precision Biologic Inc

00843876010557 - CRYOcheck Factor VIII Deficient Plasma with VWF2023-10-03 CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical laboratory use as a deficient substrate in the quantitative dete
00843876010564 - CRYOcheck Factor VIII Deficient Plasma with VWF2023-10-03 CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical laboratory use as a deficient substrate in the quantitative dete
00843876000596 - CRYOcheck Hex LA2023-05-10 CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit intended to aid in the detection of lupus anticoagulan
00843876000558 - CRYOcheck Factor VIII Chromogenic2020-08-04 CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determination of factor VIII activity in 3.
00843876000534 - CRYOcheck Lupus Negative Control2020-03-16 Prepared from human source plasma and recommended as a negative control in assays for lupus anticoagulant.
00843876000541 - CRYOcheck Lupus Negative Control2020-03-16 Prepared from human source plasma and recommended as a negative control in assays for lupus anticoagulant.
00843876000503 - CRYOcheck™ FVIII Inhibitor Kit2019-04-02 The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction with a factor VIII activity assay to enable perf
00843876000015 - CRYOcheck™ Pooled Normal Plasma2018-07-06

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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