STATSWAB3 SS3-058

GUDID 00816036028006

STATSWAB3, SS3-058 6-Panel SWAB (AMP/COC/MAMP/OPI/PCP), 25Pcs/Box

MICRO DISTRIBUTING, L.C

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID00816036028006
NIH Device Record Keybf2fc2e0-0780-460b-b546-496be3647497
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTATSWAB3
Version Model NumberSS3-058
Catalog NumberSS3-058
Company DUNS087732173
Company NameMICRO DISTRIBUTING, L.C
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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-Countertrue

Customer Support Contacts

Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com
Phone866-933-0964
Emailinfo@micro-distributing.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816036027504 [Primary]
GS100816036028006 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DKZEnzyme Immunoassay, Amphetamine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-24
Device Publish Date2021-09-16

On-Brand Devices [STATSWAB3]

00816036028020STATSWAB3, SS3-168 6-Panel SWAB (AMP/COC/MAMP/OPI/PCP/THC, 25Pcs/Box
00816036028013STATSWAB3, SS3-158 6-Panel SWAB (AMP/COC/MAMP/OPI/THC, 25Pcs/Box
00816036028006STATSWAB3, SS3-058 6-Panel SWAB (AMP/COC/MAMP/OPI/PCP), 25Pcs/Box
00816036028044STATSWAB3, SS3-068 6-Panel SWAB (AMP/COC/MAMP/OPI/OXY/PCP), 25Pcs/Box
00816036028037STATSWAB3, SS3-048 4-Panel SWAB (COC/MAMP/OPI/PCP), 25Pcs/Box

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.