Primary Device ID | 10743816000860 |
NIH Device Record Key | 4028bf03-a45b-4705-a9c5-3faa166fbdb9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Status Strep A Plus |
Version Model Number | BSP-185-05-00 |
Catalog Number | BSP-185-05-00 |
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 | 10743816000860 [Primary] |
GTY | Antigens, All Groups, Streptococcus Spp. |
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 | 2016-09-23 |
10743816000860 | Status Strep A Plus; 5 Test kit (5 Test Strip Canister) |
10743816000853 | Status Strep A Plus; 50 Test kit (2 x 25 Test Strip Canister) |