Primary Device ID | 00847627004703 |
NIH Device Record Key | f0dc1a45-b259-406f-b20b-0b1e668f0aff |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CD138 + Cyclin D1 |
Version Model Number | API3193DSAA |
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 |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00847627004703 [Primary] |
FDA | Enteroscope And Accessories |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-06-29 |
Device Publish Date | 2023-06-21 |
00847627035851 - Helicobacter pylori [EPR10353] | 2024-05-31 |
00847627033604 - intelliPATH MAX | 2024-05-08 |
00847627033666 - intelliPATH MAX | 2024-05-08 |
00847627035202 - INSM1 [BLR272L] | 2024-04-09 |
00847627035158 - INSM1 [BLR272L] | 2024-03-20 |
00847627035165 - INSM1 [BLR272L] | 2024-03-20 |
00847627035172 - INSM1 [BLR272L] | 2024-03-20 |
00847627035189 - INSM1 [BLR272L] | 2024-03-20 |