HOLOGIC PRD-05592
GUDID 15420045512566
Hologic, Inc.
Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)| Primary Device ID | 15420045512566 |
| NIH Device Record Key | e7f6e5ff-159e-427f-83f0-500fd155b8ed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HOLOGIC |
| Version Model Number | COV 229E PRIMERS (ASR) |
| Catalog Number | PRD-05592 |
| Company DUNS | 050579217 |
| Company Name | Hologic, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -85 Degrees Celsius and -15 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15420045512566 [Primary] |
FDA Product Code
| MUV | STIMULATOR, VAGUS NERVE, IMPLANTED, TREMOR |
| MVU | Reagents, specific, analyte |
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 | 2019-12-16 |
| Device Publish Date | 2019-12-06 |
On-Brand Devices [HOLOGIC]
| 15420045512610 | COV NL63 PROBE (ASR) |
| 15420045512603 | COV 229E PROBE (ASR) |
| 15420045512597 | COV OC43 PROBE (ASR) |
| 15420045512580 | COV HKU1 PROBE (ASR) |
| 15420045512573 | COV NL63 PRIMERS (ASR) |
| 15420045512566 | COV 229E PRIMERS (ASR) |
| 15420045512559 | COV OC43 PRIMERS (ASR) |
| 15420045512542 | COV HKU1 PRIMERS (ASR) |
| 15420045517424 | NG IVT Wild Type Control (Negative Control). |
| 15420045517417 | NG Res C272T IVT Control (Positive Control). |
| 15420045517400 | NG Res Probe (FAM) Analyte Specific Reagent. |
| 15420045517394 | NG Res Primers Analyte Specific Reagent. |
Trademark Results [HOLOGIC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HOLOGIC 87088681 5150254 Live/Registered |
Hologic, Inc. 2016-06-29 |
 HOLOGIC 86413347 4876768 Live/Registered |
Hologic, Inc. 2014-10-02 |
 HOLOGIC 77341464 3857248 Live/Registered |
Hologic, Inc. 2007-11-30 |
 HOLOGIC 74042785 1652292 Dead/Cancelled |
Hologic, Inc. 1990-03-26 |
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