Primary Device ID | 00847627035554 |
NIH Device Record Key | de6d7afa-b5c9-49cd-958f-05b4c534cb38 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | TLE 1 [EPR9386(2)] |
Version Model Number | ACI3301C |
Company DUNS | 806617825 |
Company Name | BIOCARE MEDICAL LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
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 |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00847627035554 [Primary] |
NJT | Immunohistochemistry Reagents And Kits |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-11-25 |
Device Publish Date | 2024-11-15 |
00847627035592 | ALI3301G7 |
00847627035585 | AVI3301G |
00847627035561 | API3301AA |
00847627035554 | ACI3301C |
00847627035547 | ACI3301A |