PBM Cardiac Marker Control LSC-300C-01

GUDID 10743816001607

PBM Cardiac Marker Control Set (2 x 1 mL)

PRINCETON BIOMEDITECH CORPORATION

Multiple cardiac marker IVD, control Multiple cardiac marker IVD, control Multiple cardiac marker IVD, control Multiple cardiac marker IVD, control Multiple cardiac marker IVD, control Multiple cardiac marker IVD, control Multiple cardiac marker IVD, control Multiple cardiac marker IVD, control Multiple cardiac marker IVD, control Multiple cardiac marker IVD, control Multiple cardiac marker IVD, control Multiple cardiac marker IVD, control Multiple cardiac marker IVD, control Multiple cardiac marker IVD, control Multiple cardiac marker IVD, control
Primary Device ID10743816001607
NIH Device Record Key633b3eaa-34cf-4417-8c66-450a95365e3b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePBM Cardiac Marker Control
Version Model NumberLSC-300C-01
Catalog NumberLSC-300C-01
Company DUNS362917692
Company NamePRINCETON BIOMEDITECH CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com
Phone800-526-2125
Emailinfo@lifesignmed.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110743816001607 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-06
Device Publish Date2022-03-29

Devices Manufactured by PRINCETON BIOMEDITECH CORPORATION

10743816001621 - Status™ COVID-19 Antigen Rapid Test for Home Use2023-10-30 Status™ COVID-19 Antigen Rapid Test for Home Use, 1 Test Kit
10743816001638 - Status™ COVID-19 Antigen Rapid Test for Home Use2023-10-30 Status™ COVID-19 Antigen Rapid Test for Home Use, 2 Test Kit
10743816001645 - Status™ COVID-19 Antigen Rapid Test for Home Use2023-10-30 Status™ COVID-19 Antigen for Home Use, 25 Test Kit
10743816000532 - BioSign® hCG card2023-07-06 BioSign® hCG card; 35 Test kit
10743816000556 - Status hCG card2023-07-06 Status hCG card; 35 Test kit
10743816000563 - Status hCG card2023-07-06 Status hCG card; 12 Test sample kit
10743816000570 - BioSign® hCG card2023-07-06 BioSign® hCG card; 35 Test kit; CE
10743816000587 - BioSign® hCG card2023-07-06 BioSign® hCG card; 10 Test kit; CE

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.