FDA.reportPublic FDA data

N/A

Primary DI
00819398028431
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
J120
Catalog number
J120
Device description
PEA w/SB/Tergitol 7 Agar 15x100 biplate, 10 plates per packDifferentiation 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
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSJCulture Media, Selective And Non-DifferentialMicrobiology1
KZICulture Media, EnrichedMicrobiology1

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

Contacts#

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

Regulatory Flags#

DUNS number
039981550
Device count
10
Premarket exempt
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
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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
10382902218088BD BBL™ BCYE AgarBECTON, DICKINSON AND COMPANYKZI2024-09-19
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
18053326000413GN BrothCOPAN ITALIA SPAJSJ2022-12-07
00816576026326N/AHARDY DIAGNOSTICSJSJ2022-11-14
00816085023670Alpha-Tec SystemsAlpha-TEC Systems, Inc.JSJ2022-08-11
00816085022567Alpha-Tec SystemsAlpha-TEC Systems, Inc.JSJ2022-08-10
00816085022628Alpha-Tec SystemsAlpha-TEC Systems, Inc.JSJ2022-08-10
00816576025022N/AHARDY DIAGNOSTICSJSJ2022-07-05
00816576024636N/AHARDY DIAGNOSTICSJSJ2022-03-03
00816576024940N/AHARDY DIAGNOSTICSJSJ2022-03-03
10814105021207ACU-DTMACUDERM, INC.JSJ2020-09-22
10814105021214ACU-DTMACUDERM, INC.JSJ2020-09-22
10814105021221ACU-SABOURAUDACUDERM, INC.JSJ2020-09-22
10814105021238ACU-NICKERSONACUDERM, INC.JSJ2020-09-22
00816576024643N/AHARDY DIAGNOSTICSJSJ2020-06-08
00816576027323N/AHARDY DIAGNOSTICSJSJ2020-06-08