Home GUDID B08810804 InTray™ GC
Primary DI B08810804
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
OTC false
Sterile false
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 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# 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 B08810800 InTray™ GC 1080 10-8000 2016-09-21 B08812630 InTray® SAB 1263 21-263-001 2018-09-12 B08815030 InTray® BHI 1503 21-503-001 2018-09-12 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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