FDA.report

StrepQuick™

Primary DI
00819398028615
Brand
StrepQuick™
Company
HARDY DIAGNOSTICS
Model
Z122
Catalog number
Z122
Device description
StrepQuick™, to aid in the identification of gram positive cocci, performs a PYR, LAP, and Esculin test StrepQuick™ test kit is intended to aid in the identification of gram-positive, catalase-negative cocci based on pyroglutamate aminopeptidase (PYR), leucine aminopeptidase (LAP), and esculin hydrolysis (ESC) activity. This test kit simplifies identification of Enterococcus spp. and group A streptococci (Streptococcus pyogenes) Contains: StrepQuick Test Card (25) 00819398027274 Developer Reagent (1) 00819398028585
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

Related Records

Contact Domains

Product Codes

CodeName
LIBDevice, General Purpose, Microbiology, Diagnostic

Product Code Classifications

CodeDeviceSpecialtyClass
LIBDevice, General Purpose, Microbiology, DiagnosticMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00819398028615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398028615008193980286158193980286150819398028615

GMDN Terms

TermDefinition
Multiple aerobic gram positive bacteria species culture isolate identification IVD, kitA collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of aerobic gram positive bacteria that have been isolated by culture from a clinical specimen. Bacteria which may be identified typically belong to the genera Staphylococcus, Enterococcus, or may represent other gram positive cocci and gram positive bacilli genera.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
800-266-2222techservice@hardydiagnostics.com

Regulatory Flags

DUNS number
039981550
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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