Validate 601bcs

GUDID 00859110005883

Validate SP1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.

MAINE STANDARDS COMPANY, LLC

Multiple clinical chemistry protein IVD, control
Primary Device ID00859110005883
NIH Device Record Key05224cbb-fa11-4117-b02a-ad4764b63baa
Commercial Distribution StatusIn Commercial Distribution
Brand NameValidate
Version Model Number601bcs
Catalog Number601bcs
Company DUNS075886031
Company NameMAINE STANDARDS COMPANY, LLC
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 Numberfalse
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

Phone1-800-377-9684
EmailMSC.info@LGCGroup.com
Phone1-800-377-9684
EmailMSC.info@LGCGroup.com
Phone1-800-377-9684
EmailMSC.info@LGCGroup.com
Phone1-800-377-9684
EmailMSC.info@LGCGroup.com
Phone1-800-377-9684
EmailMSC.info@LGCGroup.com
Phone1-800-377-9684
EmailMSC.info@LGCGroup.com
Phone1-800-377-9684
EmailMSC.info@LGCGroup.com
Phone1-800-377-9684
EmailMSC.info@LGCGroup.com
Phone1-800-377-9684
EmailMSC.info@LGCGroup.com
Phone1-800-377-9684
EmailMSC.info@LGCGroup.com
Phone1-800-377-9684
EmailMSC.info@LGCGroup.com
Phone1-800-377-9684
EmailMSC.info@LGCGroup.com
Phone1-800-377-9684
EmailMSC.info@LGCGroup.com
Phone1-800-377-9684
EmailMSC.info@LGCGroup.com
Phone1-800-377-9684
EmailMSC.info@LGCGroup.com
Phone1-800-377-9684
EmailMSC.info@LGCGroup.com
Phone1-800-377-9684
EmailMSC.info@LGCGroup.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100859110005883 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJYMulti-Analyte Controls, All Kinds (Assayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-10
Device Publish Date2020-03-02

On-Brand Devices [Validate]

00859110005265Validate GC1sv is intended for the quantitative determination of Calibration Verification/Linear
00859110005258Validate GC1vt is intended for the quantitative determination of Calibration Verification/Linear
00859110005241Validate GC1sa is intended for the quantitative determination of Calibration Verification/Linear
00859110005234Validate GC1sd is intended for the quantitative determination of Calibration Verification/Linear
00859110005227Validate GC1ri is intended for the quantitative determination of Calibration Verification/Linear
00859110005210Validate GC1ro is intended for the quantitative determination of Calibration Verification/Linear
00859110005203Validate GC1bc is intended for the quantitative determination of Calibration Verification/Linear
00859110005197Validate GC1au is intended for the quantitative determination of Calibration Verification/Linear
00859110005180Validate GC1ab is intended for the quantitative determination of Calibration Verification/Linear
00859110005142Validate Fibrinogen is intended for the quantitative determination of Calibration Verification/L
00859110005135Validate Fibrinogen is intended for the quantitative determination of Calibration Verification/L
00859110005128Validate Fibrinogen is intended for the quantitative determination of Calibration Verification/L
00859110005111Validate Heparin is intended for the quantitative determination of Calibration Verification/Line
00859110005104Validate Heparin is intended for the quantitative determination of Calibration Verification/Line
00859110005098Validate Heparin is intended for the quantitative determination of Calibration Verification/Line
00859110005081Validate D-Dimer is intended for the quantitative determination of Calibration Verification/Line
00859110005074Validate D-Dimer is intended for the quantitative determination of Calibration Verification/Line
00859110005067Validate D-Dimer is intended for the quantitative determination of Calibration Verification/Line
00859110005050Validate TDM1vt is intended for the quantitative determination of Calibration Verification/Linea
00859110005043Validate TDM1ri is intended for the quantitative determination of Calibration Verification/Linea
00859110005036Validate TDM1db is intended for the quantitative determination of Calibration Verification/Linea
00859110005029Validate TDM1bc is intended for the quantitative determination of Calibration Verification/Linea
00859110005012Validate TDM1au is intended for the quantitative determination of Calibration Verification/Linea
00859110005005Validate TDM1ab is intended for the quantitative determination of Calibration Verification/Linea
00859110005418Validate GC4 is intended for the quantitative determination of Calibration Verification/Linearit
00859110005968Validate UC1 is intended for the quantitative determination of Calibration Verification/Linearit
00859110005876Validate SP1 is intended for the quantitative determination of Calibration Verification/Linearit
00859110005838Validate Vit D is intended for the quantitative determination of Calibration Verification/Linear
00859110005814Validate Fertility 1 is intended for the quantitative determination of Calibration Verification/
00859110005746Validate LP is intended for the quantitative determination of Calibration Verification/Linearity
00859110005630Validate CM2 is intended for the quantitative determination of Calibration Verification/Linearit
00859110005593Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearit
00859110005579Validate Anemia is intended for the quantitative determination of Calibration Verification/Linea
00859110005548Validate Body Fluids is intended for the quantitative determination of Calibration Verification/
00859110005517Validate IBC is intended for the quantitative determination of Calibration Verification/Linearit
00859110005340Validate GC3 is intended for the quantitative determination of Calibration Verification/Linearit
00859110005289Validate GC2 is intended for the quantitative determination of Calibration Verification/Linearit
00859110005272Validate GC2 is intended for the quantitative determination of Calibration Verification/Linearit
00850011135174Validate THY is intended for the quantitative determination of Calibration Verification/Linearit
00850011135105Validate UC5 is intended for the quantitative determination of Calibration Verification/Linearit
00850011135044Validate UC4 is intended for the quantitative determination of Calibration Verification/Linearit
00859110005999Validate UC1 is intended for the quantitative determination of Calibration Verification/Linearit
00859110005982Validate UC1 is intended for the quantitative determination of Calibration Verification/Linearit
00859110005975Validate UC1 is intended for the quantitative determination of Calibration Verification/Linearit
00859110005951Validate Whole Blood Glucose (WBG) is intended for the quantitative determination of Calibration
00859110005944Validate HbA1c is intended for the quantitative determination of Calibration Verification/Linear
00859110005937Validate HbA1c is intended for the quantitative determination of Calibration Verification/Linear
00859110005920Validate SP3 is intended for the quantitative determination of Calibration Verification/Linearit
00859110005913Validate SP2 is intended for the quantitative determination of Calibration Verification/Linearit
00859110005906Validate SP2 is intended for the quantitative determination of Calibration Verification/Linearit

Trademark Results [Validate]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VALIDATE
VALIDATE
88101931 not registered Live/Pending
Drake Collaborative, Inc.
2018-09-01
VALIDATE
VALIDATE
87726181 not registered Dead/Abandoned
Grace Hill, LLC
2017-12-19
VALIDATE
VALIDATE
87062674 not registered Live/Pending
Terry Allerton
2016-06-07
VALIDATE
VALIDATE
86696257 4901834 Live/Registered
Verified Encounters, LLC
2015-07-17
VALIDATE
VALIDATE
86556026 not registered Dead/Abandoned
BIONIC SOLUTION, LLC
2015-03-06
VALIDATE
VALIDATE
86448501 not registered Dead/Abandoned
The McDowell Agency, Inc.
2014-11-07
VALIDATE
VALIDATE
85796269 not registered Dead/Abandoned
Validate
2012-12-06
VALIDATE
VALIDATE
78763653 3299601 Live/Registered
Loveland Products, Inc.
2005-11-30
VALIDATE
VALIDATE
78729743 not registered Dead/Abandoned
Terry A. Neves
2005-10-10
VALIDATE
VALIDATE
77645982 3738965 Dead/Cancelled
Transportation Safety & Compliance Group, Inc
2009-01-08
VALIDATE
VALIDATE
76374842 2677461 Live/Registered
Maine Standards Company, LLC
2002-02-25
VALIDATE
VALIDATE
75418492 2313004 Live/Registered
Capone Associates, Inc.
1998-01-15

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