FDA.reportPublic FDA data

N/A

Primary DI
00819398027014
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
R225
Catalog number
R225
Device description
Page's Saline, for free-living amoeba Acanthomeoba and Naegleria, 2ml fill, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20For use with Non-Nutrient Agar (Cat. No. G225) for detecting the presence of free-living amebae cysts and trophozoites in tissue, soil, or water samples.
Published
2020-06-04
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
JSCCulture Media, General Nutrient Broth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSCCulture Media, General Nutrient BrothMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819398027014PrimaryGS10
00819398027007Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398027014008193980270148193980270140819398027014
00819398027007008193980270078193980270070819398027007

GMDN Terms#

Term, Definition table
TermDefinition
Basic/simple nutrient broth culture medium IVDA non-selective, non-differential nutrient broth culture medium intended to be used to for the primary growth and isolation of typically non-fastidious microorganisms from a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
039981550
Device count
20
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816576027194HardyDisk™Z9495Z94952025-08-08
00816576027200HardyDisk™Z9491Z94912025-08-08
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

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Primary DI, Brand, Company table
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