FDA.reportPublic FDA data

N/A

Primary DI
00819398026475
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
R73BX
Catalog number
R73BX
Device description
LIM Broth, 2ml fill, 12x80mm plastic tube with red cap, order by the package of 100For the selective enrichment of Group B Streptococcus (Streptococcus agalactiae) from clinical specimens in a container compatible in the WASP instrument.
Published
2020-06-05
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
JSDCulture Media, Selective Broth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSDCulture Media, Selective BrothMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819398026475PrimaryGS10
00819398026468Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398026475008193980264758193980264750819398026475
00819398026468008193980264688193980264680819398026468

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
100
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
38053326011772LBM CABrothCOPAN ITALIA SPAJSD2025-09-22
08053326011771LBM CABrothCOPAN ITALIA SPAJSD2025-09-22
05407010128642TSB 3%:10 L bag (empty bag capacity)Lonza VerviersJSD2025-09-15
05407010128666TSB 3%:1000 L bag (empty bag capacity)Lonza VerviersJSD2025-09-15
05407010128673TSB 3%:500 L bag (empty bag capacity)Lonza VerviersJSD2025-09-15
05407010128680TSB 3%:1 L bag SAMPLELonza VerviersJSD2025-09-15
05407010128697TSB 3%:50 L bag (empty bag capacity)Lonza VerviersJSD2025-09-15
05032384003914SELENITE CYST.BROTH BASEOXOID LIMITEDJSD2025-07-23
05407010127164Tryptic Soy Broth 15g/L 100mlLonza VerviersJSD2025-05-26
05407010127171Tryptic Soy Broth 15g/L 500mlLonza VerviersJSD2025-05-26
05407010127188Tryptic Soy Broth 15g/L, 500ML bagLonza VerviersJSD2025-05-26
05407010127195Tryptic Soy Broth 15g/L 2L in 20L bagLonza VerviersJSD2025-05-26
05407010127201Tryptic Soy Broth 15g/L - 5ml tubeLonza VerviersJSD2025-05-26
054070101272183% w/v TSB, 500 ml bag Sample close systLonza VerviersJSD2025-05-26
054070101272253% w/v TSB, 500 ml bag Sample open systLonza VerviersJSD2025-05-26
054070101272323% w/v TSB - 1 L bagLonza VerviersJSD2025-05-26
054070101272493% w/v TSB - 200 L bagLonza VerviersJSD2025-05-26
054070101272563% w/v TSB - 50 L bagLonza VerviersJSD2025-05-26
05407010127263Tryptic Soy Broth 1L bag - SAMPLELonza VerviersJSD2025-05-26
05407010127270Tryptic Soy Broth 200L bagLonza VerviersJSD2025-05-26
054070101272873% W/V TSB - 1L bag SampleLonza VerviersJSD2025-05-26
054070101272943% W/V TSB - 10L bagLonza VerviersJSD2025-05-26
05407010127300TSB 3% : 1L bag SAMPLELonza VerviersJSD2025-05-26
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B645T0736EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSD2025-04-21
B645T0763EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSD2025-04-21
B645T0781EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSD2025-04-21
B645T2255EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSD2025-04-21
B645T06411EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSD2025-04-21
B645T07361EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSD2025-04-21