Home GUDID 00847627004703 CD138 + Cyclin D1
Primary DI 00847627004703
Brand CD138 + Cyclin D1
Company BIOCARE MEDICAL LLC
Model API3193DSAA
Published 2023-06-21
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name FDA Enteroscope And Accessories
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FDA Enteroscope And Accessories Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00847627004703 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 00847627004703 00847627004703 847627004703 0847627004703
GMDN Terms# Term, Definition table Term Definition Multiple solid tumour differentiation marker IVD, antibody Multiple immunoglobulins (antibody cocktail) capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of multiple proteins/markers associated with more than one specific tissue or solid tumour (e.g., lung, breast, ovarian, kidney, gastrointestinal, colon) in a clinical specimen. It is typically used in cancer-screening assays to help diagnostic differentiation between solid tumour types through detection of various types of proteins/markers (e.g., homeobox protein CDX-2, cytokeratin 7, GATA3, uroplakin).
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 806617825 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 00860014745003 FUJIFILM Stiffening Wire (SW-2000) Fujifilm Healthcare Americas Corporation FDA 2025-12-18 04547410491715 FUJIFILM FUJIFILM CORPORATION FDA 2024-07-05 04547410514056 FUJIFILM FUJIFILM CORPORATION FDA 2024-07-05 14547410491712 FUJIFILM FUJIFILM CORPORATION FDA 2024-07-05 14547410514053 FUJIFILM FUJIFILM CORPORATION FDA 2024-07-05 10197106523643 CARDINAL HEALTH Cardinal Health 200, LLC FDA 2024-01-24 50197106523641 CARDINAL HEALTH Cardinal Health 200, LLC FDA 2024-01-24 10197106447185 CARDINAL HEALTH Cardinal Health 200, LLC FDA 2023-11-09 50197106447183 CARDINAL HEALTH Cardinal Health 200, LLC FDA 2023-11-09 10860006600805 Ancora Aspero Medical, Inc. FDA 2023-10-26 04547410467284 FUJIFILM FUJIFILM CORPORATION FDA 2023-02-06 04547410324280 FUJIFILM FUJIFILM CORPORATION FDA 2023-02-06 04547410467260 FUJIFILM FUJIFILM CORPORATION FDA 2023-02-06 14547410467281 FUJIFILM FUJIFILM CORPORATION FDA 2023-02-06 04547410463439 FUJIFILM FUJIFILM CORPORATION FDA 2022-01-30 04953170165801 HANGER ADAPTER SET OLYMPUS MEDICAL SYSTEMS CORP. FDA 2021-12-17 04953170165825 PROBE ARM SET A OLYMPUS MEDICAL SYSTEMS CORP. FDA 2021-12-17 04953170165849 PROBE ARM SET B OLYMPUS MEDICAL SYSTEMS CORP. FDA 2021-12-17 04953170165740 STOPPER OLYMPUS MEDICAL SYSTEMS CORP. FDA 2021-12-16 04953170165757 WATER RESISTANT CAP OLYMPUS MEDICAL SYSTEMS CORP. FDA 2021-12-16 04953170165764 PROBE HANGER OLYMPUS MEDICAL SYSTEMS CORP. FDA 2021-12-16 06934955960246 Jade PTA Balloon Dilatation Catheter OrbusNeich Medical (ShenZhen) Co., Ltd. FDA 2020-12-25 00052569143735 HealthMart STRATEGIC SOURCING SERVICES LLC FDA 2020-07-31 10052569143732 HealthMart MCKESSON CORPORATION FDA 2020-07-31 00075289122811 ProWorks TRANZONIC COMPANIES, THE FDA 2020-04-02 70075289122810 ProWorks TRANZONIC COMPANIES, THE FDA 2020-04-02 04547410384536 FUJIFILM FUJIFILM CORPORATION FDA 2019-07-04 00811503033316 Q UROLOGICAL PERSISTENT AGUAMEDICINA Q UROLOGICAL CORPORATION FDA 2019-03-27 10811503033306 Q UROLOGICAL PERSISTENT AGUAMEDICINA Q UROLOGICAL CORPORATION FDA 2019-03-27 J021300030021 TG-98 LM Synea 400 W & H Dentalwerk Bürmoos GmbH FDA 2018-08-31