Home GUDID 00608337000078 Intercept
Primary DI 00608337000078
Brand Intercept
Company Orasure Technologies, Inc.
Model 3001-2869
Device description Intercept Collection Device
Published 2016-07-29
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name PJD Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PJD Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10608337000075 Package GS1 50 Not in Commercial Distribution 20608337000072 Package GS1 500 Not in Commercial Distribution 30608337000079 Package GS1 10 Not in Commercial Distribution 40608337000076 Package GS1 50 Not in Commercial Distribution 50608337000073 Package GS1 5 Not in Commercial Distribution 60608337000070 Package GS1 10 Not in Commercial Distribution 70608337000077 Package GS1 25 Not in Commercial Distribution 00608337000078 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 10608337000075 10608337000075 20608337000072 20608337000072 30608337000079 30608337000079 40608337000076 40608337000076 50608337000073 50608337000073 60608337000070 60608337000070 70608337000077 70608337000077 00608337000078 00608337000078 608337000078 0608337000078
GMDN Terms# Term, Definition table Term Definition Oral/upper respiratory tract specimen collection kit A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for subsequent laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture]. The kit consists of a non-suctioning sampling/collection tool(s) [e.g., swab, brush, spatula, saliva collection mouthpiece/funnel] and a covered specimen receptacle with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 18 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 114152184 Device count 1 DM 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 00840937113912 Immunalysis IMMUNALYSIS CORP PJD 2023-03-29 00840937113929 Immunalysis IMMUNALYSIS CORP PJD 2023-03-29 00840937113936 Immunalysis IMMUNALYSIS CORP PJD 2023-03-29 00840937103142 Immunalysis IMMUNALYSIS CORPORATION PJD 2023-03-29 00840937112052 Quantisal IMMUNALYSIS CORPORATION PJD 2020-10-06 00840937112069 Quantisal IMMUNALYSIS CORPORATION PJD 2020-10-06 00840937112144 Immunalysis IMMUNALYSIS CORP PJD 2020-08-31 00840937112151 Quantisal IMMUNALYSIS CORPORATION PJD 2020-08-31 00840937112168 Quantisal IMMUNALYSIS CORPORATION PJD 2020-08-31 00608337000115 OraSure Oral Fluid Collection Device Orasure Technologies, Inc. PJD 2019-02-15 20608337000119 OraSure Oral Fluid Collection Device Orasure Technologies, Inc. PJD 2019-02-15 10859952006236 Oral-Eze CAPITOL VIAL, INC. PJD 2018-08-31 30859952006261 Oral-Eze CAPITOL VIAL, INC. PJD 2018-08-31 00840937110812 Immunalysis IMMUNALYSIS CORP PJD 2018-04-20 00840937110829 Immunalysis IMMUNALYSIS CORP PJD 2018-04-20 10859952006045 Oral-Eze CAPITOL VIAL, INC. PJD 2018-01-12 00884883012639 Oral-Eze Sample Extractor Microgenics Corporation PJD 2017-12-20 00884883012646 Oral-Eze Sample Extractor Microgenics Corporation PJD 2017-12-20 00859952006093 Oral-Eze CAPITOL VIAL, INC. PJD 2017-07-25 00859952006109 Oral-Eze CAPITOL VIAL, INC. PJD 2017-07-25 00859952006055 Oral-Eze CAPITOL VIAL, INC. PJD 2017-04-27 00859952006062 Oral-Eze CAPITOL VIAL, INC. PJD 2017-04-27 00859952006079 Oral-Eze CAPITOL VIAL, INC. PJD 2017-04-27 00859952006086 Oral-Eze CAPITOL VIAL, INC. PJD 2017-04-27 00884883012585 Oral-Eze Collection System Microgenics Corporation PJD 2016-09-12 00884883012653 Oral-Eze Collection System Microgenics Corporation PJD 2016-09-12 00859952006000 Oral-Eze CAPITOL VIAL, INC. PJD 2016-09-10 00859952006017 Oral-Eze CAPITOL VIAL, INC. PJD 2016-09-10 00859952006024 Oral-Eze CAPITOL VIAL, INC. PJD 2016-09-10 00859952006031 Oral-Eze CAPITOL VIAL, INC. PJD 2016-09-10
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