AmpliVue M221
GUDID 30014613336969
Quidel Digital Heat Block
DIAGNOSTIC HYBRIDS, INC.
Laboratory heating block Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD Heating block IVD| Primary Device ID | 30014613336969 |
| NIH Device Record Key | 96d2a1e7-3bf3-46e1-9378-de112da1b12c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AmpliVue |
| Version Model Number | M221 |
| Catalog Number | M221 |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 30014613336969 [Primary] |
FDA Product Code
| JRG | BLOCK, HEATING |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-10 |
| Device Publish Date | 2019-04-02 |
On-Brand Devices [AmpliVue]
| 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 |
Trademark Results [AmpliVue]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AMPLIVUE 85140233 4147342 Live/Registered |
Quidel Corporation 2010-09-28 |
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