Primary Device ID | 10743816001447 |
NIH Device Record Key | 453f024b-fdfa-41d7-93a4-d9795ad52fdd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Status Flu A & B |
Version Model Number | BSP-510-05-00 |
Catalog Number | BSP-510-05-00 |
Company DUNS | 362917692 |
Company Name | PRINCETON BIOMEDITECH CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 8005262125 |
info@lifesignmed.com | |
Phone | 8005262125 |
info@lifesignmed.com | |
Phone | 8005262125 |
info@lifesignmed.com | |
Phone | 8005262125 |
info@lifesignmed.com | |
Phone | 8005262125 |
info@lifesignmed.com | |
Phone | 8005262125 |
info@lifesignmed.com |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10743816001447 [Primary] |
GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2022-06-10 |
Device Publish Date | 2017-10-13 |
10743816001621 - Status™ COVID-19 Antigen Rapid Test for Home Use | 2023-10-30 Status™ COVID-19 Antigen Rapid Test for Home Use, 1 Test Kit |
10743816001638 - Status™ COVID-19 Antigen Rapid Test for Home Use | 2023-10-30 Status™ COVID-19 Antigen Rapid Test for Home Use, 2 Test Kit |
10743816001645 - Status™ COVID-19 Antigen Rapid Test for Home Use | 2023-10-30 Status™ COVID-19 Antigen for Home Use, 25 Test Kit |
10743816000532 - BioSign® hCG card | 2023-07-06 BioSign® hCG card; 35 Test kit |
10743816000556 - Status hCG card | 2023-07-06 Status hCG card; 35 Test kit |
10743816000563 - Status hCG card | 2023-07-06 Status hCG card; 12 Test sample kit |
10743816000570 - BioSign® hCG card | 2023-07-06 BioSign® hCG card; 35 Test kit; CE |
10743816000587 - BioSign® hCG card | 2023-07-06 BioSign® hCG card; 10 Test kit; CE |