Home GUDID B08810800 InTray™ GC
Primary DI B08810800
Brand InTray™ GC
Company BIO-MED DIAGNOSTICS, INC.
Model 1080
Catalog number 10-8000
Device description Intended for use in the qualitative detection of oral, rectal and genitourethral Neisseria gonorrhoeae colonization.
Published 2016-09-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name JTY Culture Media, For Isolation Of Pathogenic Neisseria
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JTY Culture Media, For Isolation Of Pathogenic Neisseria Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B08810802 Package HIBCC 5 In Commercial Distribution B08810803 Package HIBCC 10 In Commercial Distribution B08810804 Package HIBCC 20 In Commercial Distribution B08810800 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Neisseria gonorrhoeae culture isolate identification IVD, kit A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of Neisseria gonorrhoeae bacteria, the causative agent of gonorrhoea which has been isolated by culture 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 605213545 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B088212730010 InTray® SAB+PVG 2127 2023-10-05 B08816120 Saline Solution (0.85%) 1612 11-612-001 2020-09-29 B08816020 VTM-C19 Transit Tube 1602 11-602-001 2020-10-05 B08815930 InTray DM-FungID 1593 21-593-001 2020-02-10 B08815934 InTray DM-FungID 1593 21-593-001 2020-02-10 B08824830 InTray® Mueller Hinton Chocolate Agar 2483 22-483-001 2019-10-16 B08824834 InTray® Mueller Hinton Chocolate Agar 2483 22-483-001 2019-10-16 B08812630 InTray® SAB 1263 21-263-001 2018-09-12 B08815030 InTray® BHI 1503 21-503-001 2018-09-12 B08810804 InTray™ GC 1080 10-8000 2016-09-21 B08812634 InTray® SAB 1263 21-263-001 2018-09-12 B08815034 InTray® BHI 1503 21-503-001 2018-09-12 B08820630 InTray® DM 2063 22-063-000 2018-09-13 B08814430 InTray® TSA 1443 21-443-001 2018-09-12 B08814434 InTray® TSA 1443 21-443-001 2018-09-12 B08810310 InPouch® TV 1031 21-031-001 2018-08-20 B08810510 InPouch® TVC Subculture 1051 21-051-001 2018-09-12 B08811030 InTray® COLOREX Screen 1103 21-103-001 2018-09-13 B08811130 InTray® COLOREX Yeast 1113 21-113-001 2018-09-13 B08812230 InTray® COLOREX Salmonella 1223 21-223-001 2018-09-12
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00816576028948 NA HARDY DIAGNOSTICS JTY 2020-03-31 00816576020072 NA HARDY DIAGNOSTICS JTY 2020-03-31 10382902213021 BD BBL™ Trypticase™ Soy Agar with 5% SB (TSA II) // Chocolate II Agar BECTON, DICKINSON AND COMPANY JTY 2016-12-21 10382902213038 BD BBL™ Trypticase™ Soy Agar with 5% SB (TSA II) // Chocolate II Agar BECTON, DICKINSON AND COMPANY JTY 2016-12-21 10382902215575 BD BBL™ Martin-Lewis Agar BECTON, DICKINSON AND COMPANY JTY 2016-12-21 10382902215582 BD BBL™ Martin-Lewis Agar BECTON, DICKINSON AND COMPANY JTY 2016-12-21 10382902215674 BD BBL™ Modified Thayer-Martin (MTM II) Agar BECTON, DICKINSON AND COMPANY JTY 2016-12-21 10382902215681 BD BBL™ Modified Thayer-Martin (MTM II) Agar BECTON, DICKINSON AND COMPANY JTY 2016-12-21 10382902216237 BD BBL™ Chocolate II Agar/Modified Thayer-Martin Agar BECTON, DICKINSON AND COMPANY JTY 2016-12-21 10382902962714 BD BBL™ Chocolate II Agar with Bacitracin BECTON, DICKINSON AND COMPANY JTY 2016-12-21 10382902977152 BD BBL™ GC-Lect™ Agar BECTON, DICKINSON AND COMPANY JTY 2016-12-21 10382902979286 BD BBL™ GC-Lect™ Agar BECTON, DICKINSON AND COMPANY JTY 2016-12-21 30382902212677 BD BBL™ Chocolate II Agar BECTON, DICKINSON AND COMPANY JTY 2016-12-21 30382902215685 BD BBL™ Modified Thayer-Martin (MTM II) Agar BECTON, DICKINSON AND COMPANY JTY 2016-12-21 30382902215586 BD BBL™ Martin-Lewis Agar BECTON, DICKINSON AND COMPANY JTY 2016-12-21 30382902962718 BD BBL™ Chocolate II Agar with Bacitracin BECTON, DICKINSON AND COMPANY JTY 2016-12-21 30382902211694 BD BBL™ Chocolate II Agar BECTON, DICKINSON AND COMPANY JTY 2016-12-21 30382902213025 BD BBL™ Trypticase™ Soy Agar with 5% SB (TSA II) // Chocolate II Agar BECTON, DICKINSON AND COMPANY JTY 2016-12-21 30382902213032 BD BBL™ Trypticase™ Soy Agar with 5% SB (TSA II) // Chocolate II Agar BECTON, DICKINSON AND COMPANY JTY 2016-12-21 30382902215579 BD BBL™ Martin-Lewis Agar BECTON, DICKINSON AND COMPANY JTY 2016-12-21 30382902215678 BD BBL™ Modified Thayer-Martin (MTM II) Agar BECTON, DICKINSON AND COMPANY JTY 2016-12-21 30382902216231 BD BBL™ Chocolate II Agar/Modified Thayer-Martin Agar BECTON, DICKINSON AND COMPANY JTY 2016-12-21 30382902977156 BD BBL™ GC-Lect™ Agar BECTON, DICKINSON AND COMPANY JTY 2016-12-21 30382902979280 BD BBL™ GC-Lect™ Agar BECTON, DICKINSON AND COMPANY JTY 2016-12-21 M20210951 MARTIN LEWIS AGAR Healthlink JTY 2016-09-24 M20211001 MODIFIED THAYER MARTIN Healthlink JTY 2016-09-24 M20217371 JEMBEC MARTIN LEWIS Healthlink JTY 2016-09-24 M202173811 JEMBEC MOD THAYER MARTIN Healthlink JTY 2016-09-24 M2027657ML2 MARTIN LEWIS G.C. SYSTEM Healthlink JTY 2016-09-24 M202V8001 MARTIN LEWIS G.C. SYSTEM Healthlink JTY 2016-09-24
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