FDA.reportPublic FDA data

N/A

Primary DI
00819398026390
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
Z81
Catalog number
Z81
Device description
Bovine Serum Albumin 0.2%, 3ml each, for enhanced growth of mycobacteria; optically clear, shatter resistant, polycarbonate tube, 20 per kitUsed for the preparation of specimens for AFB culture. A growth stimulant for Mycobacterium tuberculosis.
Published
2020-06-16
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
JSKSupplement, Culture Media

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSKSupplement, Culture MediaMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819398026390PrimaryGS10
00819398026383Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398026390008193980263908193980263900819398026390
00819398026383008193980263838193980263830819398026383

GMDN Terms#

Term, Definition table
TermDefinition
Culture medium nutrient supplement IVDA formulation of non-selective supplements containing nutrients e.g., (amino acids, sugars, minerals) or other additives (e.g., serum, haemoglobin) intend to enrich a culture medium to sustain and/or enhance the growth or isolation of a specific target microbial species 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
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
05407010128727ProLipid Complex - 50 ml SAMPLELonza VerviersJSK2025-09-15
05407010128734ProLipid Complex - 1010 mlLonza VerviersJSK2025-09-15
05407010128741Rec. Hum. Insulin ( # 4506) Suppl - 10LLonza VerviersJSK2025-09-15
05407010128758Rec. Hum. Insulin ( # 4506) Suppl - 500LLonza VerviersJSK2025-09-15
05407010128765Mod ProCHO 5 powder Sup 2 - 20 mlLonza VerviersJSK2025-09-15
05407010128772Mod ProCHO 5 powder Sup 2 - 500LLonza VerviersJSK2025-09-15
05407010128284Ferric Citrate solution - 400 mlLonza VerviersJSK2025-08-11
05407010128246Insulin Solution - 50 ml SAMPLELonza VerviersJSK2025-08-08
05407010128253Insulin Solution - 900 mlLonza VerviersJSK2025-08-08
05407010128260Ferric Citrate solution - 50 ml SAMPLELonza VerviersJSK2025-08-08
05407010128277Ferric Citrate solution - 1L bottleLonza VerviersJSK2025-08-08
05407010127126DMEM Vitamines Stock 100x 1LLonza VerviersJSK2025-05-26
05407010127010MCDB 202 Trace Element BulkLonza VerviersJSK2025-05-23
05407010127034CHO4A Trace element stock - 1L bottleLonza VerviersJSK2025-05-23
05407010127041Stock solution CH-0107N (0.7g/L)Lonza VerviersJSK2025-05-23
05407010127058Stock solution SP-0180T (0.095 g/l)Lonza VerviersJSK2025-05-23
05407010127065Stock solution CH-0146T (0.078 g/l)Lonza VerviersJSK2025-05-23
05407010127072Stock solution CH-0242 (0.4711 g/l)Lonza VerviersJSK2025-05-23
05407010127089Stock solution CH-0116N (0.2162 g/l)Lonza VerviersJSK2025-05-23
05407010127096Stock solution CH-0149N (35.67 mg/l)Lonza VerviersJSK2025-05-23
05407010127102Stock solution CH-0149N (35.67 mg/l)Lonza VerviersJSK2025-05-23
05407010127119CHO7 Lipids 2x 500 ml (resa CSL Behring)Lonza VerviersJSK2025-05-23
05407010126976Lipid Mix CM-105 NN It.no.101-5986-500mlLonza VerviersJSK2025-05-20
05407010126983Lipid Mix CM-105 NN It.no.101-5986 - 20LLonza VerviersJSK2025-05-20
05407010126648SF5-16 Powder Medium - Sup 1 for 5LLonza VerviersJSK2025-04-17
05407010126655SF5-16 Powder Medium - Sup 1 for 500LLonza VerviersJSK2025-04-17
05407010126662SF5-16 Powder Medium - Sup 2 - 5LLonza VerviersJSK2025-04-17
05407010126679SF5-16 Powder Medium - Sup 2 - 500LLonza VerviersJSK2025-04-17
05407010126426proVero complement powder - 500LLonza VerviersJSK2025-03-31
05407010126327GSK-IC-01 supplem. powder 200LLonza VerviersJSK2025-03-25