QC Sets and Panels: Helix Elite™ 8193

GUDID 70845357041080

BD MAX™ CT/GC/TV 20-Day QC Panel

MICROBIOLOGICS INC.

Multiple sexually transmitted pathogen nucleic acid IVD, control Multiple sexually transmitted pathogen nucleic acid IVD, control Multiple-type sexually transmitted pathogen nucleic acid IVD, control Multiple-type sexually transmitted pathogen nucleic acid IVD, control Multiple-type sexually transmitted pathogen nucleic acid IVD, control Multiple-type sexually transmitted pathogen nucleic acid IVD, control Multiple-type sexually transmitted pathogen nucleic acid IVD, control Multiple-type sexually transmitted pathogen nucleic acid IVD, control Multiple-type sexually transmitted pathogen nucleic acid IVD, control Multiple-type sexually transmitted pathogen nucleic acid IVD, control Multiple-type sexually transmitted pathogen nucleic acid IVD, control Multiple-type sexually transmitted pathogen nucleic acid IVD, control Multiple-type sexually transmitted pathogen nucleic acid IVD, control Multiple-type sexually transmitted pathogen nucleic acid IVD, control Multiple-type sexually transmitted pathogen nucleic acid IVD, control Multiple-type sexually transmitted pathogen nucleic acid IVD, control Multiple-type sexually transmitted pathogen nucleic acid IVD, control
Primary Device ID70845357041080
NIH Device Record Key06122cfb-bd1f-4aed-9335-73f94d29adf5
Commercial Distribution StatusIn Commercial Distribution
Brand NameQC Sets and Panels: Helix Elite™
Version Model Number8193 BD MAX™ CT/GC/TV 20-Day QC Panel
Catalog Number8193
Company DUNS060467826
Company NameMICROBIOLOGICS 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (320) 253-7400
Emailtechsupport@microbiologics.com
Phone+1 (320) 253-7400
Emailtechsupport@microbiologics.com
Phone+1 (320) 253-7400
Emailtechsupport@microbiologics.com
Phone+1 (320) 253-7400
Emailtechsupport@microbiologics.com
Phone+1 (320) 253-7400
Emailtechsupport@microbiologics.com
Phone+1 (320) 253-7400
Emailtechsupport@microbiologics.com
Phone+1 (320) 253-7400
Emailtechsupport@microbiologics.com
Phone+1 (320) 253-7400
Emailtechsupport@microbiologics.com
Phone+1 (320) 253-7400
Emailtechsupport@microbiologics.com
Phone+1 (320) 253-7400
Emailtechsupport@microbiologics.com
Phone+1 (320) 253-7400
Emailtechsupport@microbiologics.com
Phone+1 (320) 253-7400
Emailtechsupport@microbiologics.com
Phone+1 (320) 253-7400
Emailtechsupport@microbiologics.com
Phone+1 (320) 253-7400
Emailtechsupport@microbiologics.com
Phone+1 (320) 253-7400
Emailtechsupport@microbiologics.com
Phone+1 (320) 253-7400
Emailtechsupport@microbiologics.com
Phone+1 (320) 253-7400
Emailtechsupport@microbiologics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100845357041081 [Unit of Use]
GS170845357041080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PMNAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-09-16
Device Publish Date2018-11-21

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