OxiSticks™

Primary DI
00819398027137
Brand
OxiSticks™
Company
HARDY DIAGNOSTICS
Model
Z193
Catalog number
Z193
Device description
OxiSticks™ Oxidase Swabs, 25 swabs per vial For use in the detection of cytochrome oxidase activity in bacteria.
Published
2020-08-06
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
JTODiscs, Strips And Reagents, Microorganism Differentiation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTODiscs, Strips And Reagents, Microorganism DifferentiationMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819398028646PrimaryGS10
00819398027137Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398028646008193980286468193980286460819398028646
00819398027137008193980271378193980271370819398027137

GMDN Terms#

Term, Definition table
TermDefinition
Chromogenic substrate reagent IVDA reagent or solution that gives off colour in a biochemical reaction, intended to be used in combination with other IVDs in the testing of a clinical specimen, typically using an enzyme immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-266-2222techservice@hardydiagnostics.com

Regulatory Flags#

DUNS number
039981550
Device count
25
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

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