| Primary Device ID | 07611969952380 |
| NIH Device Record Key | 5c8964bf-40a8-4422-8078-fb6592b5aa7e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biotestcell® 1 & 2 |
| Version Model Number | 816014100 |
| Catalog Number | 816014100 |
| Company DUNS | 312576506 |
| Company Name | Bio-Rad Medical Diagnostics GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 800-224-6723 |
| techsupport.bmd@bio-rad.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07611969952380 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2014-09-17 |
| 03610520569870 - IH-Com | 2022-03-22 IH-Com Kit Fullversion US; Software Version: 04.0.27. |
| 03610522055685 - IH-Card ABO Neutral | 2022-03-17 The IH-Card ABO Neutral is intended for the detection of Anti-A and Anti-B antibodies to human red blood cells. |
| 07611969964505 - IH-Titration Rack | 2022-03-17 IH-Titration Rack is a rack with empty wells for plasma/serum dilution used with the IH-500. |
| 07611969952205 - IH-Titration Solution | 2022-03-11 IH-Titration Solution is a dilution medium for the titer determination of antibodies in patient and donor samples for use with a |
| 07611969233786 - IH-500 | 2022-01-31 IH-500 is an automated instrument intended for the in vitro serological analysis for blood grouping and antibody detection of hu |
| 03610522123919 - IH-Com V5.2 | 2021-02-26 IH-Com V5.2, Software Version 5.2 |
| 03610522165049 - Wash Solution A Concentrate | 2020-02-13 Wash Solution for use with the IH-500 |
| 07611969951369 - Alsevers Solution | 2019-11-27 Suspension medium and stabilizer for red blood cells for TANGO instruments and other immunohaematology methods |