Primary Device ID | 00847627040190 |
NIH Device Record Key | a5938fe8-fc74-41f0-81b5-c4180928927c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | NeoPATH Pro Pepsin |
Version Model Number | NPRI10030T40 |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | true |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00847627040190 [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 | 2025-03-28 |
Device Publish Date | 2025-03-20 |
00847627040466 - Helicobacter pylori [EPR10353] | 2025-04-28 |
00847627040473 - Helicobacter pylori [EPR10353] | 2025-04-28 |
00847627037183 - P504S (P) | 2025-04-21 |
00847627037190 - P504S (P) | 2025-04-21 |
00847627037954 - Cytokeratin LMW (8/18) | 2025-04-21 |
00847627037961 - Cytokeratin LMW (8/18) | 2025-04-21 |
00847627038616 - Cytomegalovirus (CMV) | 2025-04-21 |
00847627038685 - CD117/c-kit | 2025-04-21 |