FDA.reportPublic FDA data

N/A

Primary DI
00819398023412
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
R36
Catalog number
R36
Device description
Tryptic Soy Broth (TSB), USP, 1ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20(Tryptic Soy Broth) For sterility testing and cultivation of microorganisms. Also known as Soybean-Casein Digest Broth, USP.
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
JSCCulture Media, General Nutrient Broth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSCCulture Media, General Nutrient BrothMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819398023412PrimaryGS10
00819398023405Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398023412008193980234128193980234120819398023412
00819398023405008193980234058193980234050819398023405

GMDN Terms#

Term, Definition table
TermDefinition
Basic/simple nutrient broth culture medium IVDA non-selective, non-differential nutrient broth culture medium intended to be used to for the primary growth and isolation of typically non-fastidious 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
20
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816576027194HardyDisk™Z9495Z94952025-08-08
00816576027200HardyDisk™Z9491Z94912025-08-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975278042516JIAOYUEJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.JSC2026-04-21
06975278042523JIAOYUEJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.JSC2026-04-21
06975278042479JIAOYUEJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.JSC2026-04-18
06975278040321JIAOYUEJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.JSC2026-03-13
06975278040093personal lubricantJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.JSC2026-02-22
06975278040109personal lubricantJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.JSC2026-02-22
00810144911496Cell ProAnalytiChem USA, Inc.JSC2025-11-26
00810144911502Cell ProAnalytiChem USA, Inc.JSC2025-11-26
00810144911519Cell ProAnalytiChem USA, Inc.JSC2025-11-26
B645T0415EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T0481EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T0488EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T0755EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T0756EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T0757EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T0764EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T0765EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T04151EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T04811EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T04881EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T07551EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T07561EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T07571EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T07641EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T07651EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-21
B645T0040EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-18
B645T0041EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-18
B645T0046EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-18
B645T0047EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-18
B645T0051EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-18