FDA.reportPublic FDA data

QC Sets and Panels: Helix Elite™

Primary DI
70845357041233
Brand
QC Sets and Panels: Helix Elite™
Company
MICROBIOLOGICS INC.
Model
8196 Cepheid Xpert® SA Nasal Complete Control Pane
Catalog number
8196
Device description
Assayed SA Nasal Complete Control Panel
Published
2019-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PMNAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMNAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) AssaysMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191168000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191168000Cepheid Xpert SA Nasal Complete Control PanelMicrobiologics, Inc.2019-06-25PMN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
70845357041233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
7084535704123370845357041233

GMDN Terms#

Term, Definition table
TermDefinition
MRSA/MSSA nucleic acid IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA/MSSA) bacteria present in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1 (320) 253-7400techsupport@microbiologics.com

Regulatory Flags#

DUNS number
060467826
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
70845357041202QC Sets and Panels: Helix Elite™819081902020-04-30
10845357044409Helix Elite™ Molecular Standards: Inactivated StandardHE0082HFHE0082HF2026-04-15
70845357044340QC Sets and Panels: Helix Elite™82482025-09-08
70845357044395QC Sets and Panels: Helix Elite™82672025-09-08
70845357044432QC Sets and Panels: Helix Elite™826982692026-02-10
70845357044593QC Sets and Panels: KWIK-STIK™ 2 Pack5260P5260P2026-01-27
10845357044324Helix Elite™ Molecular Standards: Inactivated StandardHE0081NSHE0081NS2024-09-04
10845357020175KWIK-STIK™0828U0828U2020-04-30
10845357029383KWIK-STIK™01018U01018U2020-04-30
10845357020199LYFO DISK™0828L0828L2020-04-30
10845357029406LYFO DISK™01018L01018L2020-04-30
80845357044422Helix Elite Molecular StandardsGS-00012025-08-14
10845357043846Helix Elite™ Molecular Standards: Inactivated StandardHE0071NHE0071N2022-02-16
10845357043853Helix Elite™ Molecular Standards: Inactivated StandardHE0072NSHE0072NS2022-02-16
80845357044415QC Sets and Panels: Helix Elite™CL00016CL000162025-05-27
10845357043952Helix Elite™ Molecular Standards: Inactivated StandardHE0074NSHE0074NS2022-02-16
70845357041127QC Sets and Panels: Helix Elite™821482142020-04-30
10634853001364Tri-Valent™ SwabCV-01CV-012022-09-26
10634853001388Tri-Valent™ SwabTVS-01TVS-012022-09-26
10634853001395Tri-Valent™ SwabTVS-02TVS-022022-09-26

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30014613340492SavannaDIAGNOSTIC HYBRIDS, INC.PMN2024-04-30
00852720008091SPOTFIRE RSP Positive ControlMmqciPMN2023-09-15
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70845357041240QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.PMN2019-10-31
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