FDA.reportPublic FDA data

Todd Hewitt Broth + Antibiotics

Primary DI
03573026118723
Brand
Todd Hewitt Broth + Antibiotics
Company
BIOMERIEUX SA
Model
Todd Hewitt Broth + Antibiotics
Device description
selective enrichment broth for the detection of group B streptococci in pregnant women.
Published
2019-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
03573026118723PrimaryGS10
03573026598518Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026118723035730261187233573026118723
03573026598518035730265985183573026598518

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 Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
276816717
Device count
20
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03573026064532VIDAS® Measles IgG302192019-08-30
03573026064518VIDAS® Varicella-Zoster IgG302172016-08-31
03573026610418VITEK®MSVITEKMS SW v1.0 / FlexPrep v1.02019-04-30
03573026644796VIDAS® Varicella-Zoster IgG30217-012026-01-19
03573026550523ETEST® Tigecycline (TGC)Etest® TIGECYCLINE2016-12-12
03573026584139ID color CatalaseID color Catalase2019-07-19
03573026092009ID color CatalaseID color Catalase2019-07-19
03573026559823THxID™ BRAF1.02017-05-12
03573026121631VIDAS® Quality Control307062019-11-19
B0744000160ASTUTE140 Electronic Quality Control (EQC) Device4000164000162016-08-12
B0745000090NEPHROCHECK Calibration Verification (Cal Vers) Kit5000095000092016-08-12
B0745000110NEPHROCHECK Test Kit 5000115000112016-08-12
B0745000130NEPHROCHECK Liquid Control Kit5000135000132016-08-12
03573026547226ETEST® Ertapenem (ETP)ETEST® Ertapenem (ETP)2016-11-18
03573026547271ETEST® Tobramycin (TM)ETEST® Tobramycin (TM)2016-11-18
03573026547295ETEST® Tigecycline (TGC)ETEST® Tigecycline (TGC)2016-11-18
03573026548674ETEST® Ampicillin/sulbactam (2/1) (AB)ETEST® Ampicillin/sulbactam (2/1) (AB)2016-11-18
03573026549046ETEST® Tetracycline (TC)ETEST® Tetracycline (TC)2016-11-18
03573026549077ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)2016-11-18
03573026547196ETEST® Fosfomycin (FM)ETEST® Fosfomycin (FM)2016-11-18

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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B645T07361EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSD2025-04-21