Panther System 902615

GUDID 15420045504141

Hologic, Inc.

Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated Isothermal nucleic acid amplification analyser IVD, laboratory, automated
Primary Device ID15420045504141
NIH Device Record Key17239999-8d87-4ba9-923e-6481083ef84c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePanther System
Version Model Number9120900000
Catalog Number902615
Company DUNS050579217
Company NameHologic, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045504141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LSLDNA-REAGENTS, NEISSERIA

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-03-03

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