Home GUDID 00819398023528 N/A
Primary DI 00819398023528
Brand N/A
Company HARDY DIAGNOSTICS
Model R49
Catalog number R49
Device description Middlebrook 7H11 Slant, 3ml, 13x100mm tube slant, order by the package of 20 For the isolation and cultivation of Mycobacterium spp.
Published 2020-06-05
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name KZI Culture Media, Enriched
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KZI Culture Media, Enriched Microbiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00819398023535 Primary GS1 0 00819398023528 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 00819398023535 00819398023535 819398023535 0819398023535 00819398023528 00819398023528 819398023528 0819398023528
GMDN Terms# Term, Definition table Term Definition Enriched agar culture medium IVD An agar culture medium supplemented with nutrient-rich substances (e.g., blood, serum) intended to enhance the growth and isolation of fastidious microorganisms from a clinical specimen and/or culture isolate. It is typically used to cultivate microorganisms that would not otherwise grow on general-purpose agar medium.
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 20 DM exempt false Premarket exempt false 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10382902218088 BD BBL™ BCYE Agar BECTON, DICKINSON AND COMPANY KZI 2024-09-19 30382902218082 BD BBL™ BCYE Agar BECTON, DICKINSON AND COMPANY KZI 2024-09-19 00850056467063 Schaedler Blood Agar OxyPlate Oxyrase, Inc. KZI 2023-11-30 00810144911120 Redipor AnalytiChem USA, Inc. KZI 2023-09-21 00810144911144 Redipor AnalytiChem USA, Inc. KZI 2023-09-21 00810144911151 Redipor AnalytiChem USA, Inc. KZI 2023-09-21 05051716000155 AIM-V Medium Oxford Immunotec, Inc. KZI 2023-02-07 05051716000162 AIM-V Medium Oxford Immunotec, Inc. KZI 2023-02-07 00848838001505 REMEL REMEL, INC. KZI 2023-01-04 00848838010965 REMEL REMEL, INC. KZI 2023-01-04 00848838010972 REMEL REMEL, INC. KZI 2023-01-04 00848838012136 REMEL REMEL, INC. KZI 2023-01-04 00848838012174 REMEL REMEL, INC. KZI 2023-01-04 00819398020565 N/A HARDY DIAGNOSTICS KZI 2022-07-25 00819398020558 N/A HARDY DIAGNOSTICS KZI 2022-07-25 00819398028431 N/A HARDY DIAGNOSTICS KZI 2020-09-02 00816576027576 N/A HARDY DIAGNOSTICS KZI 2020-06-08 00816576027613 N/A HARDY DIAGNOSTICS KZI 2020-06-08 00819398024228 HardyFlask™ HARDY DIAGNOSTICS KZI 2020-06-08 00819398024242 HardyFlask™ HARDY DIAGNOSTICS KZI 2020-06-08 00819398024266 HardyFlask™ HARDY DIAGNOSTICS KZI 2020-06-08 00819398024235 HardyFlask™ HARDY DIAGNOSTICS KZI 2020-06-08 00816576027262 N/A HARDY DIAGNOSTICS KZI 2020-06-05 00816576027477 N/A HARDY DIAGNOSTICS KZI 2020-06-05 00819398023535 N/A HARDY DIAGNOSTICS KZI 2020-06-05 00819398022194 N/A HARDY DIAGNOSTICS KZI 2020-06-03 00819398022293 N/A HARDY DIAGNOSTICS KZI 2020-06-03 00819398028127 N/A HARDY DIAGNOSTICS KZI 2020-06-03 00819398022187 N/A HARDY DIAGNOSTICS KZI 2020-06-03 00819398022286 N/A HARDY DIAGNOSTICS KZI 2020-06-03
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