FDA.report

QC Sets and Panels: KWIK-STIK™

Primary DI
70845357035676
Brand
QC Sets and Panels: KWIK-STIK™
Company
MICROBIOLOGICS INC.
Model
8173
Catalog number
8173
Device description
QC Sets and Panels: KWIK-STIK™ GBS Verification Panel (Live Culture)
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

Related Records

Contact Domains

Product Codes

CodeName
OHQMulti-analyte controls unassayed

Product Code Classifications

CodeDeviceSpecialtyClass
OHQMulti-Analyte Controls UnassayedClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
70845357035676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
7084535703567670845357035676

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

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
true
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 DIBrandModelCatalogPublished
10634853001364Tri-Valent™ SwabCV-01CV-012022-09-26
70845357044432QC Sets and Panels: Helix Elite™826982692026-02-10
70845357044593QC Sets and Panels: KWIK-STIK™ 2 Pack5260P5260P2026-01-27
70845357044340QC Sets and Panels: Helix Elite™82482025-09-08
70845357044395QC Sets and Panels: Helix Elite™82672025-09-08
80845357044422Helix Elite Molecular StandardsGS-00012025-08-14
10845357044324Helix Elite™ Molecular Standards: Inactivated StandardHE0081NSHE0081NS2024-09-04
70845357044364QC Sets and Panels: Helix Elite™826882682024-09-04
70845357044388QC Sets and Panels: Helix Elite™8246-SPL8246-SPL2024-03-18
10634853000138Fungal Serology200150-1200150-12022-09-26
10634853000145Fungal Serology200150-3200150-32022-09-26
10634853000152Fungal Serology200150-8200150-82022-09-26
10634853000169Fungal Serology2001552001552022-09-26
10634853000176Fungal Serology2001602001602022-09-26
10634853000183Fungal Serology2001652001652022-09-26
10634853000206Fungal Serology2001802001802022-09-26
10634853000213Fungal Serology2001852001852022-09-26
10634853000220Fungal Serology2001902001902022-09-26
10634853000237Fungal Serology2001952001952022-09-26
10634853000244Fungal Serology2002002002002022-09-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
70845357044432QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2026-02-10
00852720008244Birlinn™ CoV2-Flu-RSV Control Panel M509MmqciOHQ2025-12-04
01220000260634NATtrol™ ZEPTOMETRIX CORPORATIONOHQ2025-12-01
70845357044340QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2025-09-08
70845357044395QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2025-09-08
05056850400038Mimix™ Quantitative Multiplex FFPE reference standardREVVITY DISCOVERY LIMITEDOHQ2025-08-15
80845357044422Helix Elite Molecular StandardsMICROBIOLOGICS INC.OHQ2025-08-14
01220000260627NATtrol™ ZEPTOMETRIX CORPORATIONOHQ2025-08-06
04987270235584Lumipulse Infectious Disease ControlsFUJIREBIO INC.OHQ2025-07-31
01220000260481NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-07-25
08718734962991CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734963004CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734963011CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734963028CueSee® BGEMEurotrol B.V.OHQ2025-07-25
01220000260498NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-07-23
00850051429578Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2025-06-20
00850051429639Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2025-06-20
00850051429684Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2025-06-20
05056850400007Mimix™ OncoSpan FFPE Reference StandardREVVITY DISCOVERY LIMITEDOHQ2025-06-05
05056850400014Mimix™ OncoSpan gDNA Reference StandardREVVITY DISCOVERY LIMITEDOHQ2025-06-05
05056850400021Mimix™ Myeloid Cancer Panel gDNA Reference StandardREVVITY DISCOVERY LIMITEDOHQ2025-06-05
01220000260542NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-03-06
08718734962526CueSee VeriSTAT®Eurotrol B.V.OHQ2024-10-29
08718734962618CueSee VeriSTAT®Eurotrol B.V.OHQ2024-10-29
08718734962625CueSee VeriSTAT®Eurotrol B.V.OHQ2024-10-29
08718734962632CueSee VeriSTAT®Eurotrol B.V.OHQ2024-10-29
10845357044324Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.OHQ2024-09-04
70845357044364QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2024-09-04
03610522384372Exact DiagnosticsEXACT DIAGNOSTICS, LLCOHQ2024-08-27
03610522384389Exact DiagnosticsEXACT DIAGNOSTICS, LLCOHQ2024-08-27