STATCUP® SCP-3257-0-A

GUDID 00816036026538

STATCUP 5 Panel Test Cup w/Adulterants, COC/mAMP/OPI/PCP/THC + CR,OX,pH , 25Pcs/Box

MICRO DISTRIBUTING, L.C

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00816036026538
• NIH Device Record Key: 24db45e5-130a-4edb-9a6e-7ab3cc7f43c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STATCUP®
• Version Model Number: SCP-3257-0-A
• Catalog Number: SCP-3257-0-A
• Company DUNS: 087732173
• Company Name: MICRO DISTRIBUTING, L.C
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com
• Phone: 866-933-0964
• Email: info@micro-distributing.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816036026538 [Primary]
GS1	00816036027030 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133968

FDA Product Code

• DIO: Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-10
• Device Publish Date: 2019-07-02

On-Brand Devices [STATCUP® ]

• 00816036021618: STAT DOA 5 in 1 CLIA WaivedTest Cup, 25Pcs/Box THC/COC/OPI/mAMP/PCP
• 00816036021571: STAT DOA 11 in 1 CLIA Waived Dipcard, 25Pcs/Box AMP/BARB/BUP/BZO/COC/mAMP/MOR/MTD/OXY/PCP/THC
• 00816036021380: STAT DOA 10 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC
• 00816036021373: STAT DOA 10 in 1 Test Cup W/AD, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MOR/MTD/OXY/PCP/THC/PH-SG-OX
• 00816036021366: STAT DOA 10 in 1 Test Cup W/AD + ALCO, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MOR/MTD/OXY/PCP/THC+pH,SG,
• 00816036021359: STAT DOA 10 in 1 Test Cup W/AD, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC/PH-SG-OX
• 00816036021342: STAT DOA 8 in 1 Test Cup W/AD, 25Pcs/Box AMP/BZO/COC/mAMP/MOR/MTD/OXY/THC/PH-SG-OX
• 00816036021335: STAT DOA 8 in 1 Test Cup, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MOR/PCP/THC/PH-SG-OX
• 00816036021328: STAT 7 in 1 Test Cup W/AD, 25Pcs/Box AMP/BZO/COC/mAMP/MOR/OXY/THC+pH-SG-OX
• 00816036021311: STAT 6 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box AMP/BZO/COC/mAMP/OPI/THC/PH-SG-OX
• 00816036021304: STAT 6 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box COC/BZO/mAMP/MOR/OXY/THC+pH,SG,OX
• 00816036021298: STAT DOA 6 in 1 CLIA Waived Test Cup，25Pcs/Box AMP/BZO/COC/mAMP/OPI/THC
• 00816036021281: STAT DOA 5 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box AMP/COC/mAMP/OPI/THC/PH-SG-OX
• 00816036021274: STAT DOA 5 in 1 CLIA Waived Test Cup, 25Pcs/Box BZO/COC/mAMP/MOR/THC
• 00816036021267: STAT DOA 5 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box THC/COC/OPI/mAMP/PCP/PH-SG-OX
• 00816036021250: STAT DOA 5 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/THC
• 00816036021243: STAT DOA 5 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box BZO/COC/mAMP/MOR/THC/PH-SG-OX
• 00816036021236: STAT DOA 4 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box COC/mAMP/OPI/THC/PH-SG-OX
• 00816036021229: STAT DOA 4 in 1 CLIA Waived Test Cup, 25Pcs/Box COC/mAMP/OPI/THC
• 00816036021212: STAT DOA 3 in 1 CLIA Waived Test Cup, 25Pcs/Box COC/mAMP/THC
• 00816036026576: STATCUP 10 Panel Test Cup w/Adulterants, AMP/BAR/BZO/COC/mAMP/MOP/MTD/OXY/PCP/THC + CR,OX,pH , 2
• 00816036026569: STATCUP 10 Panel Test Cup w/Adulterants, AMP/BAR/BZO/COC/mAMP/MTD/OPI/PCP/PPX/THC + CR,OX,pH, 25
• 00816036026552: STATCUP 10 Panel Test Cup, AMP/BAR/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC , 25Pcs/Box
• 00816036026545: STATCUP 6 Panel Test Cup w/Adulterants, AMP/BZO/COC/mAMP/OPI/THC + CR,OX,pH , 25Pcs/Box
• 00816036026538: STATCUP 5 Panel Test Cup w/Adulterants, COC/mAMP/OPI/PCP/THC + CR,OX,pH , 25Pcs/Box
• 00816036026521: STATCUP 5 Panel Test Cup, COC/mAMP/OPI/PCP/THC , 25Pcs/Box
• 00816036026514: STATCUP 5 Panel Test Cup w/Adulterants, 25Pcs/Box AMP/COC/mAMP/OPI/THC + CR,OX,pH
• 00816036026507: STATCUP 5 Panel Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/THC
• 00816036027115: STATCUP SCP-32107-0-A,10 Panel Test Cup w/Adulterants, AMP/BAR/BUP/BZO/COC/mAMP/MTD/MOR/OXY/THC
• 00816036027108: STATCUP 6 Panel Test Cup w/Adulterants, BZO/COC/mAMP/MOR/OXY/THC + CR,OX,pH , 25Pcs/Box
• 00816036027092: STATCUP 5 Panel Test Cup w/Adulterants, BZO/COC/mAMP/MOR/THC + CR,OX,pH , 25Pcs/Box
• 00816036026583: STATCUP 6 Panel CLIA Waived Test Cup, 25Pcs/Box AMP/BZO/COC/mAMP/OPI/THC
• 00816036027122: STATCUP 7 Panel Test Cup w/Adulterants, AMP/BZO/COC/mAMP/MOR/OXY/THC + CR,OX,pH , 25Pcs/Box
• 00816036027139: STATCUP 12 Panel Test Cup w/Adulterants, AMP/BAR/BZO/COC/mAMP/MDMA/MOP/MTD/OXY/PCP/PPX/THC + CR,
• 00816036027160: STATCUP 10 Panel Test Cup, AMP/BAR/BZO/COC/mAMP/MTD/OPI/PCP/PPX/THC), 25Pcs/Box
• 00816036027153: STATCUP 8 Panel Test Cup w/Adulterants, AMP/BZO/COC/mAMP/MOR/MTD/OXY/THC + CR,OX,pH , 25Pcs/Box
• 00816036027146: STATCUP 5 Panel Test Cup, BZO/COC/mAMP/MOR/THC , 25Pcs/Box
• 00816036021946: STAT DOA 12 in 1 CLIA Waived Dipcard, 25Pcs/Box AMP/BARB/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/PPX/
• 00816036021588: STAT DOA 10 in 1 Test Cup W/AD, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MTD/OPI/PCP//PPX/THC/PH-SG-OX
• 00816036021670: STAT DOA 12 in 1 Test Cup W/AD, 25Pcs/Box AMP/BAR/BUP/BZO/COC/mAMP/MOR/MTD/MDMA/OXY/PCP/THC/PH-
• 00816036021649: STAT DOA 12 in 1 Test Cup W/AD, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MOR/MTD/MDMA/OXY/PCP/THC/PPX/PH-
• 00816036021625: STAT DOA 10 in 1 Test Cup W/AD, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MTD/OPI/PCP//PPX/THC/
• 00816036021694: STAT DOA 10 in 1 Test Cup W/AD, 25Pcs/Box AMP/BAR/BUP/BZO/COC/mAMP/MOR/MTD/OXY/THC/PH-SG-OX
• 00816036027177: STATCUP 10 Panel Test Cup, AMP/BAR/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC + CR,OX,pH , 25Pcs/Box
• 00816036025494: STATCUP 9 Panel Test Cup w/Adulterants, AMP/BAR/BZO/COC/mAMP/MOR/MTD/PCP/THC + CR,OX,pH , 25Pcs/