Primary Device ID | 15420045506848 |
NIH Device Record Key | f8a10858-780f-4819-9577-893f3b3be4c2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ATEC EMERALD |
Version Model Number | ATEC EMERALD |
Company DUNS | 018925968 |
Company Name | Hologic, Inc. |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
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 |
Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 15420045506848 [Primary] |
KNW | INSTRUMENT, BIOPSY |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-30 |
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15420045511439 - Panther Fusion® | 2024-06-18 Cytomegalovirus (CMV) Probe ASR. |
15420045511484 - Panther Fusion® | 2024-06-18 Varicella zoster virus (VZV) Primers ASR. |
15420045511491 - Panther Fusion® | 2024-06-18 Varicella zoster virus (VZV) Probe ASR. |
15420045512115 - Panther Fusion® | 2024-06-18 Hologic CMV Plasmid Control. |
15420045512146 - Panther Fusion® | 2024-06-18 Hologic VZV Plasmid Control. |
15420045513877 - DIGITAL DIAGNOSTICS SYSTEM | 2024-06-17 The Genius™ digital imager creates digital images of glass slides as part of the Genius™ digital diagnostics system. |
15420045513884 - DIGITAL DIAGNOSTICS SYSTEM | 2024-06-17 Computer to operate the Genius™ Digital Imager. |