FDA.reportPublic FDA data

N/A

Primary DI
00819398028028
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
J120
Catalog number
J120
Device description
PEA w/SB/Tergitol 7 Agar 15x100 biplate, 10 plates per pack Differentiation and isolation of gram-negative and gram-positive organisms (as well as fermenting characteristics), preventing of Proteus swarming, differentiation of gram-positive organisms, early detector of yeast (growth on both PEA & T7 with white colonies).
Published
2020-09-02
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
JSJCulture Media, Selective And Non-Differential

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819398028431PrimaryGS10
00819398028028Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398028431008193980284318193980284310819398028431
00819398028028008193980280288193980280280819398028028

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
039981550
Device count
10
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

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
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
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
B6454P330EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B645T0800EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6454P230EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-17
B645T0004EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-17
B645T0631EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-17
10382902978791BD BBL™ BCYE Selective Agar w/PACBECTON, DICKINSON AND COMPANYJSJ2024-09-17
10382902981913BD BBL™ Inhibitory Mold Agar Deep FillBECTON, DICKINSON AND COMPANYJSJ2024-08-29
10382902216015BD BBL™ Columbia CNA Agar with 5% SB and BD BBL MacConkey II Agar BD I Plate™BECTON, DICKINSON AND COMPANYJSJ2024-08-23
00848838001048REMELREMEL, INC.JSJ2023-01-03
00848838001055REMELREMEL, INC.JSJ2023-01-03
00848838001086REMELREMEL, INC.JSJ2023-01-03
00848838001093REMELREMEL, INC.JSJ2023-01-03
00848838001116REMELREMEL, INC.JSJ2023-01-03
00848838001437REMELREMEL, INC.JSJ2023-01-03
00848838001451REMELREMEL, INC.JSJ2023-01-03
00848838000119REMELREMEL, INC.JSJ2022-12-30
00848838000201REMELREMEL, INC.JSJ2022-12-30
00848838000348REMELREMEL, INC.JSJ2022-12-30
00848838000355REMELREMEL, INC.JSJ2022-12-30
00848838000423REMELREMEL, INC.JSJ2022-12-30
00848838000430REMELREMEL, INC.JSJ2022-12-30
00848838000447REMELREMEL, INC.JSJ2022-12-30
00848838000461REMELREMEL, INC.JSJ2022-12-30