LifeSign® MI CK-MB/Myo/TnI card LSC-300-20-00

GUDID 10743816001324

LifeSign® MI CK-MB/Myo/TnI; 20 Test kit

PRINCETON BIOMEDITECH CORPORATION

Troponin I IVD, kit, rapid ICT, clinical
Primary Device ID10743816001324
NIH Device Record Key9bfd7c44-f83c-4f16-8e5c-c4ed82d94f13
Commercial Distribution StatusIn Commercial Distribution
Brand NameLifeSign® MI CK-MB/Myo/TnI card
Version Model NumberLSC-300-20-00
Catalog NumberLSC-300-20-00
Company DUNS362917692
Company NamePRINCETON BIOMEDITECH CORPORATION
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8005262125
Emailinfo@lifesignmed.com
Phone8005262125
Emailinfo@lifesignmed.com
Phone8005262125
Emailinfo@lifesignmed.com
Phone8005262125
Emailinfo@lifesignmed.com
Phone8005262125
Emailinfo@lifesignmed.com
Phone8005262125
Emailinfo@lifesignmed.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110743816001324 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DEAMyoglobin, Fitc, Antigen, Antiserum, Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-06-10
Device Publish Date2016-09-23

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Trademark Results [LifeSign]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LIFESIGN
LIFESIGN
81025669 1025669 Dead/Cancelled
Big Three Industries, Inc.
0000-00-00
LIFESIGN
LIFESIGN
80995966 0995966 Dead/Cancelled
Medical Profile Systems, Inc.
0000-00-00
LIFESIGN
LIFESIGN
75120017 not registered Dead/Abandoned
WELCH ALLYN, INC.
1996-06-17
LIFESIGN
LIFESIGN
75103524 2235586 Dead/Cancelled
Coss Development Corporation
1996-04-18
LIFESIGN
LIFESIGN
74280941 1790064 Live/Registered
Princeton BioMeditech Corporation
1992-06-03
LIFESIGN
LIFESIGN
74125291 1663311 Live/Registered
PICs, Inc.
1990-12-20
LIFESIGN
LIFESIGN
74114052 not registered Dead/Abandoned
Feste, Catherine
1990-11-07
LIFESIGN
LIFESIGN
73666184 1490885 Live/Registered
HEALTH INNOVATIONS, INC.
1987-06-12

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