AmpliVue M201
GUDID 30014613312017
AmpliVue CDiff Assay
QUIDEL CORPORATION
Multiple enterovirus immunoglobulin M (IgM) antibody IVD, control| Primary Device ID | 30014613312017 |
| NIH Device Record Key | f0b16714-74c8-43fa-b36d-6ec457d2a593 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AmpliVue |
| Version Model Number | C. difficile Assay |
| Catalog Number | M201 |
| Company DUNS | 079509836 |
| Company Name | QUIDEL CORPORATION |
| 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 | 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 30014613312017 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123355
FDA Product Code
| OZN | C.Difficile toxin gene amplification assay |
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 | 2016-09-15 |
On-Brand Devices [AmpliVue]
| 30014613312123 | AmpliVue GAS Assay |
| 30014613312116 | AmpliVue Trichomonas Assay |
| 30014613312109 | AmpliVue HSV 1+2 Assay |
| 30014613312093 | AmpliVue Bordetella Assay |
| 30014613312024 | AmpliVue GBS Assay |
| 30014613312017 | AmpliVue CDiff Assay |
Trademark Results [AmpliVue]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AMPLIVUE 85140233 4147342 Live/Registered |
Quidel Corporation 2010-09-28 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.