PA500 Portrait Analyzer PA500

GUDID B178PA5000

GREAT BASIN SCIENTIFIC, INC.

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Primary Device IDB178PA5000
NIH Device Record Key125bde7d-9182-45a1-af9e-f054a3fa4403
Commercial Distribution StatusIn Commercial Distribution
Brand NamePA500 Portrait Analyzer
Version Model NumberPA500
Catalog NumberPA500
Company DUNS827115259
Company NameGREAT BASIN SCIENTIFIC, INC.
Device Count1
DM Exemptfalse
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com
Phone(888) 333-9763
Emailcustomersupport@gbscience.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB178PA5000 [Primary]

FDA Product Code

NSUInstrumentation For Clinical Multiplex Test Systems

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-23

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