FDA.reportPublic FDA data

KWIK-STIK™

Primary DI
20845357017363
Brand
KWIK-STIK™
Company
MICROBIOLOGICS INC.
Model
0718U
Catalog number
0718U
Device description
KWIK-STIK™ C. jejuni NCTC 11322
Published
2020-04-30
Public version status
New
Distribution status
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
20845357017363PackageGS12In Commercial Distribution
30845357017377PackageGS16In Commercial Distribution
10845357017366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084535701736320845357017363
3084535701737730845357017377
1084535701736610845357017366

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
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
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