FDA.reportPublic FDA data

N/A

Primary DI
00819398025829
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
Y41
Catalog number
Y41
Device description
Moeller's Decarboxylase Base (control), 5ml fill, 16x125mm tube, order by the package of 20For the differentiation of gram negative enteric bacilli based on the decarboxylation reaction of amino acids. A control tube for use with Y42, Y43, and Y44.
Published
2020-06-09
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
JSHCulture Media, Non-Selective And Differential

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K880121000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K880121000MOELLERS DECARBOXYLASE, BASEHardy Media1988-03-31JSH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819398025829PrimaryGS10
00819398025812Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398025829008193980258298193980258290819398025829
00819398025812008193980258128193980258120819398025812

GMDN Terms#

Term, Definition table
TermDefinition
Differential/selective broth culture medium IVDA broth culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing in the same medium. It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.

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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B645T0722EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
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B645T0772EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0775EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B64507151EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07111EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07131EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07141EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07181EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07221EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07711EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07721EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07751EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B6453B014EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6454P355EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6454P444EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B645T0096EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6453B0141EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6454P3551EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6454P4441EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B645B0318EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B645T00961EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6452P185EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-17
B6453P080EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-17