QC Sets and Panels: Helix Elite™ 8190

GUDID 70845357041202

QC Sets and Panels: Helix Elite™ Enterovirus (EV) Control Panel (Inactivated Swab)

MICROBIOLOGICS INC.

Multiple respiratory virus nucleic acid IVD, control
Primary Device ID70845357041202
NIH Device Record Keyd72db5ec-b9e0-46fe-a263-7d8d1bf15fa8
Commercial Distribution StatusIn Commercial Distribution
Brand NameQC Sets and Panels: Helix Elite™
Version Model Number8190
Catalog Number8190
Company DUNS060467826
Company NameMICROBIOLOGICS INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptionfalse
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
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS170845357041202 [Primary]

FDA Product Code

OHQMulti-analyte controls unassayed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-08
Device Publish Date2020-04-30

On-Brand Devices [QC Sets and Panels: Helix Elite™]

70845357041394BD MAX™ Enteric Parasite Control Panel
70845357041219The Cepheid Xpert® GBS LB Control Panel is used to monitor DNA extraction, amplification and de
70845357041097BD MAX™ Enteric Parasite 20-Day QC Panel
70845357041080BD MAX™ CT/GC/TV 20-Day QC Panel
70845357041240Cepheid Xpert® Respiratory Control Panel
70845357043084QC Sets and Panels: Helix Elite™ Multi-Strain Human Papillomavirus (HPV) Verification Panel (I
70845357043077QC Sets and Panels: Helix Elite™ Multi-Strain Human Papillomavirus (HPV) Control Panel (Inacti
70845357043060QC Sets and Panels: Helix Elite™ Gastrointestinal (22 Targets) Control Panel (Inactivated Pell
70845357043053QC Sets and Panels: Helix Elite™ Mycoplasma genitalium Control Panel (Inactivated Pellet)
70845357042810QC Sets and Panels: Helix Elite™ Rifampicin-Resistant Mycobacterium tuberculosis Positive Cont
70845357042803QC Sets and Panels: Helix Elite™ Rifampicin-Resistant Mycobacterium tuberculosis Negative Cont
70845357042742QC Sets and Panels: Helix Elite™ Respiratory (4 Targets) Control Panel (Inactivated Swab)
70845357042735QC Sets and Panels: Helix Elite™ Group B Streptococcus (GBS) Control Panel (Inactivated Swab)
70845357042728QC Sets and Panels: Helix Elite™ Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control P
70845357042711QC Sets and Panels: Helix Elite™ C. difficile Control Panel (Inactivated Swab)
70845357042704QC Sets and Panels: Helix Elite™ Comprehensive Enteric Bacterial Control Panel (Inactivated Pe
70845357042698QC Sets and Panels: Helix Elite™ Enteric Parasite Control Panel (Inactivated Pellet)
70845357042681QC Sets and Panels: Helix Elite™ CT/GC/TV Control Panel (Inactivated Pellet)
70845357042506QC Sets and Panels: Helix Elite™ Respiratory (21 Targets) Control Panel
70845357041493QC Sets and Panels: Helix Elite™ Group A Streptococcus (GAS) Control Panel
70845357041486QC Sets and Panels: Helix Elite™ Blood Culture Identification (BCID) Verification Panel (Inact
70845357041455QC Sets and Panels: Helix Elite™ Respiratory Pathogens (16 Strains) Control Panel (Inactivated
70845357041448QC Sets and Panels: Helix Elite™ Enteric Pathogens Control Panel (Inactivated Pellet)
70845357041431QC Sets and Panels: Helix Elite™ Gram-Negative Blood Culture Control Panel (Inactivated Pellet
70845357041424QC Sets and Panels: Helix Elite™ Gram-Positive Blood Culture Control Panel (Inactivated Pellet
70845357041400QC Sets and Panels: Helix Elite™ Norovirus Control Panel (Inactivated Swab)
70845357041387QC Sets and Panels: Helix Elite™ Vancomycin Resistant Enterococcus (VRE) Control Panel (Inacti
70845357041363QC Sets and Panels: Helix Elite™ Extended Enteric Bacterial Verification Panel (Inactivated Pe
70845357041356QC Sets and Panels: Helix Elite™ Enteric Parasite Verification Panel (Synthetic)
70845357041325QC Sets and Panels: Helix Elite™ Vaginal Control Panel
70845357041318QC Sets and Panels: Helix Elite™ Vaginal Verification Panel
70845357041202QC Sets and Panels: Helix Elite™ Enterovirus (EV) Control Panel (Inactivated Swab)
70845357041196QC Sets and Panels: Helix Elite™ Trichomonas vaginalis (TV) Control Panel (Inactivated Swab)
70845357041172QC Sets and Panels: Helix Elite™ Carbapenem-resistant Enterobacteriaceae (CRE) Control Panel (
70845357041165QC Sets and Panels: Helix Elite™ Blood Culture Identification (BCID) Control Panel (Inactivate
70845357041158QC Sets and Panels: Helix Elite™ Enteric Viral Control Panel
70845357041141QC Sets and Panels: Helix Elite™ Enteric Viral Verification Panel
70845357041134QC Sets and Panels: Helix Elite™ Human Papillomavirus (HPV) Verification Panel
70845357041127QC Sets and Panels: Helix Elite™ Human Papillomavirus (HPV) Control Panel
70845357041189Cepheid Xpert® CT/NG Control Panel
70845357043619QC Sets and Panels: Helix Elite™ Respiratory Control Panel (22 Targets)
70845357043602QC Sets and Panels: Helix Elite™ Flu/RSV/SARS-CoV-2 Control Panel (Inactivated Swab)
80845357043708QC Sets and Panels: Helix Elite™ SARS-CoV-2 Verification Panel
70845357044128Helix Elite™ Molecular Standards Multiplex Vaginal Control Panel
70845357044098Helix Elite™ Molecular Standards Blood Culture Identification Control Panel (43 Targets)
70845357043749Helix Elite™ Molecular Standards Candida vaginitis/Trichomonas vaginalis (CV/TV) Control Panel
70845357043732Helix Elite™ Molecular Standards Bacterial vaginosis (BV) Control Panel
70845357043695QC Sets and Panels: Helix Elite™ Multiplex Vaginal Verification Panel
70845357043664QC Sets and Panels: Helix Elite™ Pneumonia (33 Targets) Control Panel
70845357044197QC Sets and Panels: Helix Elite™ Rapid Group B Streptococcus (GBS) Verification Panel

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.