Home GUDID 00816870021300 903 DBS Collection Cards - 5 Samples
Primary DI 00816870021300
Brand 903 DBS Collection Cards - 5 Samples
Company MONOBIND, INC.
Model 621MM
Catalog number 621MM
Published 2024-09-13
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name PJC Newborn screening specimen collection paper
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PJC Newborn Screening Specimen Collection Paper Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816870021300 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 00816870021300 00816870021300 816870021300 0816870021300
GMDN Terms# Term, Definition table Term Definition Dried blood spot collection card IVD A device intended to be used for dried blood spot collection and preservation, at the point-of-care, for subsequent diagnostic testing or screening. It is typically in the form of paper integrated in a card, on which a whole blood specimen is applied and absorbed onto the collection paper. The card may include a form to capture patient demographic information This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Width 3 Inch
Regulatory Flags# DUNS number 083155515 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00816870021096 Anti-H. Pylori IgM AccuBind ELISA Test System - 96 Wells 1525-300 1525-300A 2019-02-11 00816870021102 Anti-H. Pylori IgG AccuBind ELISA Test System - 96 Wells 1425-300 1425-300A 2019-02-11 00816870023441 PCT AccuLite CLIA Test System - 96 Wells 9275-300 9275-300A 2024-09-13 00816870023458 PCT AccuLite CLIA Test System - 192 Wells 9275-300 9275-300B 2024-09-13 00816870023465 PCT AccuBind ELISA Test System - 96 Wells 9225-300 9225-300A 2024-09-13 00816870023472 PCT AccuBind ELISA Test System - 192 Wells 9225-300 9225-300B 2024-09-13 00816870020006 NeoLumax CLIA Analyzer IN010 IN010 2024-09-13 00816870020013 LuMatic CLIA Analyzer IN008 IN008 2024-09-13 00816870020044 Immunoassay Plate Washer IN002 IN002 2024-09-13 00816870020051 NeoEldex ELISA Analyzer IN009 IN009 2024-09-13 00816870020068 PrisMatic ELISA Analyzer IN013 IN013 2024-09-13 00816870020075 Autoplex G1 ELISA Analyzer IN006 IN006 2024-09-13 00816870020082 Autoplex G2 ELISA + CLIA Analyzer IN006-2 IN006-2 2024-09-13 00816870020402 PTH Intact AccuBind ELISA Test System - 96 Wells 9025-300 9025-300A 2024-09-13 00816870021010 PAPP-A AccuBind ELISA Test System - 192 Wells 12625-300 12625-300B 2024-09-13 00816870021164 N-17-OHP AccuBind ELISA Test System - 96 Wells 5525-300 5525-300A 2024-09-13 00816870021171 N-17-OHP AccuBind ELISA Test System - 192 Wells 5525-300 5525-300B 2024-09-13 00816870021188 N-17-OHP AccuBind ELISA Test System - 480 Wells 5525-300 5525-300D 2024-09-13 00816870021195 N-17-OHP AccuBind ELISA Test System - 960 Wells 5525-300 5525-300E 2024-09-13 00816870021201 N-17-OHP AccuBind ELISA Test System - 1920 Wells 5525-300 5525-300F 2024-09-13
Other Devices Sharing Product Codes# 
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