| Primary Device ID | 10888234002208 |
| NIH Device Record Key | 97a53134-46be-4514-8e6a-975dd83a2846 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Anti-S (Monoclonal) Gamma-clone |
| Version Model Number | 0004814 |
| Catalog Number | 0004814 |
| Company DUNS | 061446282 |
| Company Name | IMMUCOR, INC. |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-855-466-8267 |
| tech_support@immucor.com |
| Storage Environment Temperature | Between 1 Degrees Celsius and 10 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888234002208 [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 | 2016-04-14 |
| 10888234002215 | Anti-s (Monoclonal) Gamma-clone reagent is intended for the detection of the s (MNS4) antigen |
| 10888234002208 | Anti-S (Monoclonal) Gamma-clone reagent is intended for the detection of the S (MNS3) antigen |
| 10888234002437 | Anti-S (Monoclonal) Gamma-clone reagent is intended for the detection of the S (MNS3) antigen |
| 10888234002420 | Anti-s (Monoclonal) Gamma-clone reagent is intended for the detection of the s (MNS4) antigen |