FDA.reportPublic FDA data

N/A

Primary DI
00816576026531
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
J122
Catalog number
J122
Device description
BBE/PEA Biplate, 15x100 biplate, 10/pk(Section i: Bacteroides Bile Esculin Agar; Section II: Anerobic Phenylethyl Alcohol Agar) For the selective isolation and detection of anaerobic bacteria
Published
2020-06-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSICulture Media, Selective And Differential
JSJCulture Media, Selective And Non-Differential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSICulture Media, Selective And DifferentialMicrobiology1
JSJCulture Media, Selective And Non-DifferentialMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816576026531PrimaryGS10
00816576024483Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576026531008165760265318165760265310816576026531
00816576024483008165760244838165760244830816576024483

GMDN Terms#

Term, Definition table
TermDefinition
Multiple formulation agar culture medium IVDA combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms from a clinical specimen.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
800-266-2222techservice@hardydiagnotics.comf

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819398026086N/AY62Y622020-06-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10382902149832BD BBL™ CHROMagar™ SalmonellaBECTON, DICKINSON AND COMPANYJSJ2026-04-03
10382902218729BD BBL™ TCBS AgarBECTON, DICKINSON AND COMPANYJSJ2026-04-03
B6453P395EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-21
B645T0496EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-21
B645T0577EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-21
B645T0762EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-21
B6451R009EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6453P275EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6453P390EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6454P256EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6454P290EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454P330EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6454P360EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454P371EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454P372EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454P401EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454Q194EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454T207EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B645T0432EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B645T0800EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6451P206EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6451R111EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6451R180EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6453P140EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6454P155EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6454P156EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6454P230EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-17
B6454P375EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6454P376EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B645T0004EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-17