Home GUDID 00816576025817 N/A
Primary DI 00816576025817
Brand N/A
Company HARDY DIAGNOSTICS
Model J330
Catalog number J330
Device description TSA / CET (Cetrimide Selective Agar) / MSA (Mannitol Salt Agar), USP, 15x100mm Triplate, 7ml/section. Hardy Diagnostics Cetrimide Selective Agar is recommended for the selective isolation and identification of Pseudomonas aeruginosa. Hardy Diagnostics Mannitol Salt Agar (MSA) is recommended for use as a selective and differential medium for the isolation of pathogenic staphylococci. Hardy Diagnostics Tryptic Soy Agar (TSA), USP is recommended for use as a general growth medium for the detection and enumeration of microorganisms from non-clinical samples.
Published 2020-05-20
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true
Product Codes# Code, Name table Code Name JSG Culture Media, Non-Selective And Non-Differential JSI Culture Media, Selective And Differential
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JSG Culture Media, Non-Selective And Non-Differential Microbiology 1 JSI Culture Media, Selective And Differential Microbiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816576025817 Primary GS1 0 00816576024667 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00816576025817 00816576025817 816576025817 0816576025817 00816576024667 00816576024667 816576024667 0816576024667
GMDN Terms# Term, Definition table Term Definition Multiple formulation agar culture medium IVD A combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms from a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 039981550 Device count 10 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B645T0466 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSG 2025-04-21 B645T0486 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSG 2025-04-21 B645T0496 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSI 2025-04-21 B645T0577 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSI 2025-04-21 B645T0749 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSG 2025-04-21 B645T0759 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSG 2025-04-21 B645T0762 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSI 2025-04-21 B6451B265 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSG 2025-04-18 B6451R007 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSG 2025-04-18 B6454P290 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSI 2025-04-18 B6454P360 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSI 2025-04-18 B6454P371 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSI 2025-04-18 B6454P372 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSI 2025-04-18 B6454P401 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSI 2025-04-18 B6454Q194 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSI 2025-04-18 B6454T207 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSI 2025-04-18 B645GB477 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSG 2025-04-18 B645T0006 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSG 2025-04-18 B645T0246 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSG 2025-04-18 B645T0432 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSI 2025-04-18 B6451P206 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSI 2025-04-17 B6451R111 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSI 2025-04-17 B6451R180 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSI 2025-04-17 B6452P195 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSG 2025-04-17 B6453P140 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSI 2025-04-17 B6454P145 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSG 2025-04-17 B6454P155 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSI 2025-04-17 B6454P156 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSI 2025-04-17 B6454P375 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSI 2025-04-17 B6454P376 EDGE BIOLOGICALS INC EDGE BIOLOGICALS, INC. JSI 2025-04-17