Status hCG controls BSP-121C-00

GUDID 10743816000624

Status hCG Pos/Neg controls (2 x 2.5 mL)

PRINCETON BIOMEDITECH CORPORATION

Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control Total human chorionic gonadotropin IVD, control
Primary Device ID10743816000624
NIH Device Record Key1cddf0ff-2e9f-4f58-9206-f2ba920e7e46
Commercial Distribution StatusIn Commercial Distribution
Brand NameStatus hCG controls
Version Model NumberBSP-121C-00
Catalog NumberBSP-121C-00
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

Phone8005262125
Emailinfo@lifesignmed.com
Phone8005262125
Emailinfo@lifesignmed.com
Phone8005262125
Emailinfo@lifesignmed.com
Phone8005262125
Emailinfo@lifesignmed.com
Phone8005262125
Emailinfo@lifesignmed.com
Phone8005262125
Emailinfo@lifesignmed.com
Phone8005262125
Emailinfo@lifesignmed.com
Phone8005262125
Emailinfo@lifesignmed.com
Phone8005262125
Emailinfo@lifesignmed.com
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 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
GS110743816000624 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-07-06
Device Publish Date2016-09-23

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
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