STATCUP® II STATⅡ-0257

GUDID 00816036021762

STAT II DOA 5 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/COC/MAMP/OPI/PCP

MICRO DISTRIBUTING, L.C

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00816036021762
NIH Device Record Key082bd1b3-86f3-4268-a474-33ba7dc01f43
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTATCUP® II
Version Model NumberSTATⅡ-0257
Catalog NumberSTATⅡ-0257
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100816036021762 [Primary]
GS100816036021779 [Unit of Use]

FDA Product Code

LCMEnzyme Immunoassay, Phencyclidine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-05-28
Device Publish Date2018-04-25

On-Brand Devices [STATCUP® II]

00816036025159STATCUP II 14 Panel Test Cup W/AD, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/PPX/TCA/THC +
00816036025142STATCUP II 12 Panel Test Cup W/AD, AMP/BARB/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/TCA/THC + PH-CR-OX
00816036025135STATCUP II 12 Panel Test Cup W/AD, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC + PH-CR-OX
00816036025128STATCUP II 12 Panel Test Cup, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC, 25Pcs/Box
00816036025111STATCUP II 10 Panel Test Cup W/AD, AMP/BAR/BZO/COC/mAMP/MOR/MTD/OXY/PCP/THC + PH-CR-OX, 25Pcs/Bo
00816036025104STATCUP II 10 Panel Test Cup, AMP/BAR/BZO/COC/mAMP/MOR/MTD/OXY/PCP/THC, 25Pcs/Box
00816036025098STATCUP II 10 Panel Test Cup, AMP/BAR/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC, 25Pcs/Box
00816036025081STATCUP II 10 Panel Test Cup W/AD, AMP/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/THC + PH-CR-OX, 25Pcs/B
00816036025074STATCUP II 8 Panel Test Cup W/AD, AMP/BZO/COC/mAMP/MOR/MTD/OXY/THC + pH-CR-OX, 25Pcs/Box
00816036025050STATCUP II 6 Panel Test Cup W/AD, BZO/COC/mAMP/MOR/OXY/THC + pH-CR-OX, 25Pcs/Box
00816036025043STATCUP II 6 Panel Test Cup W/AD, AMP/BZO/COC/mAMP/MOR/THC + PH-CR-OX, 25Pcs/Box
00816036025036STATCUP II 6 Panel Test Cup, 25Pcs/Box AMP/BZO/COC/mAMP/MOR/THC
00816036025029STATCUP II 5 Panel Test Cup, 25Pcs/Box BZO/COC/mAMP/MOR/THC
00816036025012STATCUP II 5 Panel Test Cup W/AD, AMP/COC/mAMP/OPI/THC + pH-CR-OX, 25Pcs/Box
00816036025005STATCUP II 5 Panel Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/THC
00816036021830STAT II DOA 6 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box BZO/COC/mAMP/MOR/OXY/THC
00816036021816STAT II DOA 6 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box AMP/COC/mAMP/OPI/PCP/THC + pH,CR, OX
00816036021793STAT II DOA 6 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/PCP/THC
00816036021762STAT II DOA 5 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/COC/MAMP/OPI/PCP
00816036021748STAT II DOA 6 in 1 CLIA Waived Test Cup, 25Pcs/Box BZO/COC/EDDP/MOR/MTD/THC
00816036021724STAT II DOA 10 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box AMP/BUP/BZO/COC/mAMP/MOR/MTD/MDMA/OXY/T
00816036021632STAT II DOA 5 in 1 Test Cup, 25Pcs/Box BZO/COC/mAMP/MOR/THC
00816036021595STAT II DOA 10 in 1 CLIA WAIVED Test Cup W/AD, 25Pcs/Box AMP/BARB/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/
00816036020994STAT II DOA 14 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box AMP/BARB/BUP/BZO/COC/EDDP/mAMP/MDMA/MOR
00816036020987STATCUP II, 12 Panel CLIA WAIVED Test Cup W/AD, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/T
00816036020970STAT II DOA 12 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box AMP/BARB/BZO/COC/mAMP/MDMA/MOR/MTD/OXY
00816036020963STAT II DOA 12 in 1 Test Cup W/AD, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/TCA/THC/P
00816036020956STAT II DOA 12 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/BARB/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/T
00816036020949STATCUP II, 12 Panel CLIA WAIVED Test Cup W/AD, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/T
00816036020932STATCUP II, 12 Panel CLIA WAIVED Test Cup, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC, 2
00816036020925STAT II DOA 10 in 1 Test Cup W/AD, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/THC/PH-SG-OX
00816036020918STAT II DOA 10 in 1 Test Cup, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC
00816036020901STAT II DOA 10 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MOR/MTD/OXY/PCP/TH
00816036020895STAT II DOA 10 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MOR/MTD/OXY/PCP/THC
00816036020871STAT II DOA 8 in 1 Test Cup W/AD, 25Pcs/Box AMP/BZO/COC/mAMP/MOR/MTD/OXY/THC + pH, CR, OX
00816036020840STAT II DOA 6 in 1 Test Cup W/AD, 25Pcs/Box BZO/COC/mAMP/MOR/OXY/THC + pH - CR- OX
00816036020833STAT II DOA 6 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box AMP/BZO/COC/mAMP/MOR/THC/PH-CR-OX
00816036020826STAT II DOA 6 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/BZO/COC/mAMP/MOR/THC
00816036020819STAT II DOA 5 in 1 Test Cup W/AD, 25Pcs/Box AMP/COC/mAMP/OPI/THC+pH,SG,OX
00816036020802STAT II DOA 5 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/THC
00816036020796STAT II DOA 5 in 1 CLIA Waived Test Cup, 25Pcs/Box BZO/COC/mAMP/OPI/THC
00816036025364STATCUP II 5 Panel CLIA Waived Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/PCP
00816036025449STATCUP II 8 Panel Test Cup W/AD, AMP/BUP/BZO/COC/mAMP/MDMA/MOR//THC, 25Pcs/Box
00816036025418STATCUP II 12 Panel OTC Test Cup, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC, 1 test per
00816036025401STATCUP II 6 Panel CLIA Waived Test Cup, with Adulterants 25Pcs/Box AMP/COC/mAMP/OPI/PCP/THC +pH
00816036025388STATCUP II 6 Panel CLIA Waived Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/PCP/THC
00816036025340STATCUP II 12 Panel CLIA Waived Test Cup W/AD, AMP/BARB/BZO/BUP/COC/EDDP/mAMP/MDMA/MOR/MTD/OXY/P
00816036025463STATCUP II 10 Panel Test Cup W/AD, AMP/BAR/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/ + PH-CR-OX, 25Pcs/
00816036021908STAT II DOA 4 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/COC/OPI/PCP
00816036025487STATCUP II 4 Panel CLIA Waived Test Cup, 25Pcs/Box AMP/COC/OPI/PCP
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.