FDA.report

N/A

Primary DI
00819398024679
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
Y104
Catalog number
Y104
Device description
Purple Broth with Dextrose, 10ml, 16x125mm tube with durham tube, order by the package of 20 For the determination of carbohydrate fermentation by bacteria, especially enteric bacilli and Enterococcus spp. Contains a durham tube for gas detection.
Published
2020-06-09
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

Related Records

Contact Domains

Product Codes

CodeName
JSICulture Media, Selective And Differential

Product Code Classifications

CodeDeviceSpecialtyClass
JSICulture Media, Selective And DifferentialMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00819398024686PrimaryGS10
00819398024679Unit of UseGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorUPC-AEAN-13Conversion note
00819398024686140081939802468608193980246860819398024686Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion.
00819398024679140081939802467908193980246790819398024679Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion.

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
800-266-2222techservice@hardydiagnostics.com

Regulatory Flags

DUNS number
039981550
Device count
20
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 DIBrandModelCatalogPublished
00816576027958N/AW95W952020-06-08
00819398024594N/AY100Y1002020-06-08
00819398023603N/AR76BXR76BX2020-06-05
00819398024235HardyFlask™X26X262020-06-08
00816576027088HardyDisk™Z9491Z94912025-08-08
00816576026975HardyDisk™Z9485Z94852025-07-14
00816576027439 QwikIDIG06020C03IG06020C032025-06-23
00819398027199N/AZ134Z1342020-06-10
00819398027779N/AZ135Z1352020-06-10
00816576023516N/A102010202020-05-26
00816576025800TransPROTPV50TPV502024-10-08
00816576026951N/AG367G3672024-07-08
00816576026586N/AJ139J1392020-05-20
00816576026876N/AR12R122024-03-08
00819398021593N/AR63BXR63BX2024-01-15
00819398020602N/AK02K022020-05-24
00816576026838HardyCHROM™J28J282023-12-08
00816576024391AnaeroGROAG051AG0512020-05-12
00819398020725HardyDisk™Z9465Z94652023-11-21
00819398023627N/AR80R802020-06-05

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00842558116709Spectra™ Candida Agar REMEL, INC.JSI2026-02-09
00810144911526RediporAnalytiChem USA, Inc.JSI2026-01-27
00848838003158Strep Selective II AgarREMEL, INC.JSI2026-01-16
00810144911472RediporAnalytiChem USA, Inc.JSI2025-11-26
B645GB123EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-21
B645T04961EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-21
B645T05771EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-21
B645T07621EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-21
B6454P2901EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454P3601EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454P3711EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454P3721EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454P4011EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454Q1941EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454T2071EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B645T04321EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6451P2061EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6451R1111EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6451R1801EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6453P1401EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6454P1551EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6454P1561EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6454P3751EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6454P3761EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B645T02361EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
00810144911359Northeast Laboratory ServicesNortheast Laboratory Services, Inc.JSI2025-01-12
05032384082919ORSAB SELECTIVE SUPPLEMENTOXOID LIMITEDJSI2024-10-29
05032384083237OXACILLIN RES. SCREENING AGAR BASEOXOID LIMITEDJSI2024-10-29
30382902978825BD BBL™ Pseudosel™ Agar (Cetrimide Agar)BECTON, DICKINSON AND COMPANYJSI2024-09-19
30382902149829BD BBL™ CHROMagar™ Staph aureusBECTON, DICKINSON AND COMPANYJSI2024-08-28