FDA.reportPublic FDA data

LYFO DISK™

Primary DI
10845357001549
Brand
LYFO DISK™
Company
MICROBIOLOGICS INC.
Model
0154L
Catalog number
0154L
Device description
LYFO DISK™ L. monocytogenes (4e) ATCC 19118™
Published
2020-04-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
10845357001549PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084535700154910845357001549

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 Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
060467826
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10845357000160LYFO DISK™0104L0104L2020-04-30
10845357000191LYFO DISK™0105L0105L2020-04-30
10845357000436LYFO DISK™0116L0116L2020-04-30
10845357001129LYFO DISK™0140L0140L2020-04-30
10845357001150LYFO DISK™0141L0141L2020-04-30
10845357001181LYFO DISK™0142L0142L2020-04-30
10845357001242LYFO DISK™0144L0144L2020-04-30
10845357001716LYFO DISK™0159L0159L2020-04-30
80845357044415QC Sets and Panels: Helix Elite™CL00016CL000162025-05-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00742860100680OSOM BVBlue Transport SwabsSekisui Diagnostics, LLCJTR2026-02-23
00742860100062OSOM BV Blue Control KitSekisui Diagnostics, LLCJTR2025-12-29
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