Home GUDID 00816387020261 IMMY
Primary DI 00816387020261
Brand IMMY
Company Immuno-Mycologics, Inc.
Model CB0050
Device description Cryptococcus Antigen External Positive Control
Published 2016-09-24
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 MVU Reagents,Specific,Analyte
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MVU Reagents, Specific, Analyte Pathology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816387020261 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00816387020261 00816387020261 816387020261 0816387020261
GMDN Terms# Term, Definition table Term Definition Cryptococcus neoformans antigen IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from the yeast Cryptococcus neoformans in a clinical specimen.
Regulatory Flags# DUNS number 099550915 Device count 1 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 00382906718167 Horizon Becton, Dickinson And Company MVU 2026-09-24 00382906718174 Horizon Becton, Dickinson And Company MVU 2026-09-24 00382906718181 Horizon Becton, Dickinson And Company MVU 2026-09-24 00382906718198 Horizon Becton, Dickinson And Company MVU 2026-09-24 00382906718204 Horizon Becton, Dickinson And Company MVU 2026-09-24 00382906718211 Horizon Becton, Dickinson And Company MVU 2026-09-24 00382906718235 Horizon Becton, Dickinson And Company MVU 2026-09-24 00382906718242 Horizon Becton, Dickinson And Company MVU 2026-09-24 00382906718259 Horizon Becton, Dickinson And Company MVU 2026-09-24 00382906718266 Horizon Becton, Dickinson And Company MVU 2026-09-24 00382906718273 Horizon Becton, Dickinson And Company MVU 2026-09-24 00382906718280 Horizon Becton, Dickinson And Company MVU 2026-09-24 00382906718310 Horizon Becton, Dickinson And Company MVU 2026-09-24 00382906718327 Horizon Becton, Dickinson And Company MVU 2026-09-24 00382906718334 Horizon Becton, Dickinson And Company MVU 2026-09-24 00382906718341 Horizon Becton, Dickinson And Company MVU 2026-09-24 00382906718358 Not Applicable Becton, Dickinson And Company MVU 2026-09-24 00382906718365 Horizon Becton, Dickinson And Company MVU 2026-09-24 00382906718372 Horizon Becton, Dickinson And Company MVU 2026-09-24 00382906718389 Horizon Becton, Dickinson And Company MVU 2026-09-24 00382906718396 Horizon Becton, Dickinson And Company MVU 2026-09-24 00840542202094 Anti-Hepatitis B Virus Core Antigen (HBcAg) BIOGENEX LABORATORIES MVU 2026-09-22 00840542202100 Anti-Hepatitis B Virus Core Antigen (HBcAg) BIOGENEX LABORATORIES MVU 2026-09-22 00840542202117 Anti-Hepatitis B Virus Core Antigen (HBcAg) BIOGENEX LABORATORIES MVU 2026-09-22 00840542202186 Anti-Herpes Simplex Virus Type II (HSV II) BIOGENEX LABORATORIES MVU 2026-09-22 00840542202193 Anti-Herpes Simplex Virus Type II (HSV II) BIOGENEX LABORATORIES MVU 2026-09-22 00840542202209 Anti-Herpes Simplex Virus Type II (HSV II) BIOGENEX LABORATORIES MVU 2026-09-22 00840542202216 Anti-Herpes Simplex Virus Type II (HSV II) BIOGENEX LABORATORIES MVU 2026-09-22 00840542202223 Anti-Herpes Simplex Virus Type II (HSV II) BIOGENEX LABORATORIES MVU 2026-09-22 00840542202230 Anti-Herpes Simplex Virus Type II (HSV II) BIOGENEX LABORATORIES MVU 2026-09-22