Anti-PR MU328-100
GUDID 00850646007136
BIOGENEX LABORATORIES
Progesterone receptor IVD, antibody| Primary Device ID | 00850646007136 |
| NIH Device Record Key | f022df5f-cf93-4440-848d-4277b0ec98bb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Anti-PR |
| Version Model Number | MU328-100 |
| Catalog Number | MU328-100 |
| Company DUNS | 042697045 |
| Company Name | BIOGENEX LABORATORIES |
| 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 | 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 |
Customer Support Contacts
| Phone | +1 (800) 421-4149 |
| support@biogenex.com |
Device Dimensions
| Total Volume | 0.1 Milliliter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store at 2-8°c |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850646007136 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K012960
FDA Product Code
| MXZ | Immunohistochemistry Assay,Antibody,Progesterone Receptor |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-14 |
Devices Manufactured by BIOGENEX LABORATORIES
| 00810119675187 - ANTI-PAX5 | 2023-05-29 |
| 00810119675972 - ANTI-HLA-DR | 2023-05-29 |
| 00810119676061 - Anti- c-Myc | 2023-05-29 |
| 00810119676221 - LIQUID DAB, CHROMOGEN | 2023-05-29 |
| 00810119676252 - H.PYLORI | 2023-05-29 |
| 00850646007327 - AEC (Aminoethylcarbazole) | 2023-05-29 |
| 00850646007334 - AEC Substrate Pack | 2023-05-29 |
| 00850646007341 - Diluent | 2023-05-29 |
Trademark Results [Anti-PR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ANTI-PR 90594320 not registered Live/Pending |
Joto Ventures, LLC 2021-03-22 |
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