| Primary Device ID | 30014613336051 | 
| NIH Device Record Key | c33a3f37-8ac2-42fc-8297-d9ded9705767 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | AmpliVue | 
| Version Model Number | M218 | 
| Catalog Number | M218 | 
| Company DUNS | 117359612 | 
| Company Name | DIAGNOSTIC HYBRIDS, INC. | 
| 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 | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 30014613336051 [Primary] | 
| JRG | BLOCK, HEATING | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-02-05 | 
| Device Publish Date | 2020-01-28 | 
| 30014613336976 | Quidel Digital Heat Block - 230V | 
| 30014613336969 | Quidel Digital Heat Block | 
| 30014613336044 | AmpliVue 95 Heatblock Set | 
| 30014613336051 | AmpliVue 95 Heatblock 230V | 
| 30014613312154 | AmpliVue 64 Heatblock Set | 
| 30014613312147 | AmpliVue Heatblock Insert | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  AMPLIVUE  85140233  4147342 Live/Registered | Quidel Corporation 2010-09-28 |