FDA.reportPublic FDA data

Helix Elite™ Molecular Standards: Inactivated Standard

Primary DI
10845357043754
Brand
Helix Elite™ Molecular Standards: Inactivated Standard
Company
MICROBIOLOGICS INC.
Model
HE0068AG
Catalog number
HE0068AG
Device description
Helix Elite™ Molecular Standards SARS-CoV-2 Whole Virus Antigen Control (Swab)
Published
2022-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MJZKit, Direct Antigen, Positive Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJZKit, Direct Antigen, Positive ControlClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10845357043754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084535704375410845357043754

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 antigen 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 antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
060467826
Device count
1
Premarket exempt
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816862027303WELLlife™WONDFO USA CO., LTD.MJZ2026-06-01
30014613340768QuickVue™WONDFO USA CO., LTD.MJZ2025-10-31
08809115900401QuickFinder™ COVID-19/Flu Antigen Pro Control Swab KitOSANG HEALTHCARE Co., Ltd.MJZ2025-03-12
15099590745172ACCESS HIV Ag/Ab combo QCBeckman Coulter, Inc.MJZ2024-03-15
10811877010712BinaxNOW® Malaria Positive Control KitAlere Scarborough, Inc.MJZ2016-09-03