FDA.reportPublic FDA data

LYFO DISK™

Primary DI
10845357019681
Brand
LYFO DISK™
Company
MICROBIOLOGICS INC.
Model
0809L
Catalog number
0809L
Device description
LYFO DISK™ C. krusei ATCC 14243™
Published
2020-04-30
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
JTRKIT, QUALITY CONTROL FOR CULTURE MEDIA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTRKit, Quality Control For Culture MediaMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10845357019681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084535701968110845357019681

GMDN Terms#

Term, Definition table
TermDefinition
Multiple bacteria species culture isolate identification control IVD, kitA collection of reagents and other associated materials intended to be used to verify the performance of one or multiple biochemical tests used for the differentiation and/or identification of multiple bacteria species that have been isolated by culture from a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 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
10845357000047KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000078KWIK-STIK™ PlusMICROBIOLOGICS INC.JTR2020-04-30
10845357000146KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000177KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000207KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000238KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000269KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000290KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000320KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000351KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000412KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000474KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000504KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000535KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000566KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000597KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000689KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000719KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000740KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000771KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000801KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000832KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000863KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000924KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000955KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000986KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357001075KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357001105KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357001136KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357001167KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30