N/A

Primary DI
00819398026857
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
Z14
Catalog number
Z14
Device description
Rapid Anginosus ID Kit, to assist in the identification of Streptococcus anginosis (S. milleri), 10 tests per kitFor the rapid identification of the Streptococcus anginosus group (formerly S. milleri) by the detection of arginine decarboxylase activity and production of acetoin. Results in as little as four hours. Easy color change readout, time saving kit format is cost effective.Each kit contains:10 tubes of Rapid Arginine10 tubes of Rapid VP
Published
2020-06-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSECulture Media, Multiple Biochemical Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSECulture Media, Multiple Biochemical TestMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819398026857PrimaryGS10
00819398027045Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398026857008193980268578193980268570819398026857
00819398027045008193980270458193980270450819398027045

GMDN Terms#

Term, Definition table
TermDefinition
Voges-Proskauer (VP) microbial reagent IVDOne or multiple substances or reactants, referred to as VP (Voges-Proskauer) reagent, intended to be used in microbial testing to determine the ability of a microorganism, isolated from a clinical specimen by culture, to convert pyruvate to acetoin.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
039981550
Device count
10
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816576020058NAE31E312016-09-01
00816576024995N/AG123G1232020-05-18
00816576026968N/AG367G3672024-07-08
00816576027965N/AW95W952020-06-08
00819398028653N/AZ206Z2062020-08-06
00816576027958N/AW95W952020-06-08
00816576024858N/AG105G1052020-05-18
00819398024600N/AY100Y1002020-06-08
00819398024808N/AY110Y1102020-06-09
00819398024907N/AY115Y1152020-06-09
00819398024594N/AY100Y1002020-06-08
00819398023610N/AR76BXR76BX2020-06-05
00819398024242HardyFlask™X26X262020-06-08
00819398025102N/AY130Y1302020-06-09
00819398023603N/AR76BXR76BX2020-06-05
00819398024235HardyFlask™X26X262020-06-08
00819398022118N/AL22L222020-06-03
00819398025560N/AY310Y3102020-06-09
00819398028264N/AMV1MV12020-06-04
00816576027194HardyDisk™Z9495Z94952025-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810144911076RediporAnalytiChem USA, Inc.JSE2023-09-21
00819398026543N/AHARDY DIAGNOSTICSJSE2020-08-07
00819398026536N/AHARDY DIAGNOSTICSJSE2020-08-07
00819398023757N/AHARDY DIAGNOSTICSJSE2020-06-05
00819398022774N/AHARDY DIAGNOSTICSJSE2020-06-04
00819398022767N/AHARDY DIAGNOSTICSJSE2020-06-04
00819398020855N/AHARDY DIAGNOSTICSJSE2020-05-24
00819398020848N/AHARDY DIAGNOSTICSJSE2020-05-24
30382902982662BD BBL™ Motility lndole Lysine Sulfide MediumBECTON, DICKINSON AND COMPANYJSE2018-05-25