FDA.report

QC Sets and Panels: KWIK-STIK™

Primary DI
70845357028623
Brand
QC Sets and Panels: KWIK-STIK™
Company
MICROBIOLOGICS INC.
Model
8164
Catalog number
8164
Device description
QC Sets and Panels: KWIK-STIK™ GBS QC Set (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
70845357028623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
7084535702862370845357028623

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

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