InActiv Blue

GUDID 05411967003471

InActiv Blue is a pathogen-inactivating and DNA/RNA stabilizing medium used for transport of naso- or oropharyngeal swabs, or saliva sampled from patients for in vitro diagnostic testing on the presence of genetic material of a virus by RT-qPCR or other molecular method (SARS-CoV-2, Influenza A/B, RSV A/B).

Fertipro NV

Oral/respiratory tract specimen container IVD, additive/medium
Primary Device ID05411967003471
NIH Device Record Keye76f535c-18e9-469b-93b8-1b19a1401b93
Commercial Distribution StatusIn Commercial Distribution
Brand NameInActiv Blue
Version Model NumberIB_TUB
Company DUNS373904101
Company NameFertipro NV
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS105411967003464 [Primary]
GS105411967003471 [Package]
Contains: 05411967003464
Package: Rack [50 Units]
In Commercial Distribution
GS105411967003488 [Package]
Contains: 05411967003464
Package: Carboard box [1200 Units]
In Commercial Distribution
GS105411967003778 [Package]
Contains: 05411967003464
Package: Carboard box [400 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QBDMicrobial Nucleic Acid Storage And Stabilization Device

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-22
Device Publish Date2024-08-14

Devices Manufactured by Fertipro NV

05411967003471 - InActiv Blue2024-08-22InActiv Blue is a pathogen-inactivating and DNA/RNA stabilizing medium used for transport of naso- or oropharyngeal swabs, or saliva sampled from patients for in vitro diagnostic testing on the presence of genetic material of a virus by RT-qPCR or other molecular method (SARS-CoV-2, Influenza A/B, RSV A/B).
05411967003471 - InActiv Blue2024-08-22 InActiv Blue is a pathogen-inactivating and DNA/RNA stabilizing medium used for transport of naso- or oropharyngeal swabs, or sa
05411967000050 - HOS Test2023-04-28 Sperm vitality test The hypo-osmotic swelling test is a sperm vitality test based on the principle that live spermatozoa swell d
05411967001231 - FertiCult High Viscosity Oil2023-03-08 FertiCult High Viscosity Oil - HVOIL050P (50ml in PETG bottle) is pre-washed with water, ready to use, high viscosity mineral oi
05411967001248 - FertiCult High Viscosity Oil2023-03-08 FertiCult High Viscosity Oil - HVOIL100P (100ml in PETG bottle) is pre-washed with water, ready to use, high viscosity mineral o
05411967001255 - FertiCult High Viscosity Oil2023-03-08 FertiCult High Viscosity Oil - HVOIL500P (500ml in PETG bottle) is pre-washed with water, ready to use, high viscosity mineral o
05411967001187 - FertiCult High Viscosity Oil2023-03-08 FertiCult High Viscosity Oil - HVOIL050 (50ml in glass bottle) is pre-washed with water, ready to use, high viscosity mineral oi
05411967001200 - FertiCult High Viscosity Oil2023-03-08 FertiCult High Viscosity Oil - HVOIL100 (100ml in glass bottle) is pre-washed with water, ready to use, high viscosity mineral o
05411967001224 - FertiCult High Viscosity Oil2023-03-08 FertiCult High Viscosity Oil - HVOIL500 (500ml in glass bottle) is pre-washed with water, ready to use, high viscosity mineral o

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