STATCUP® II STATII-0247-0

GUDID 00816036025487

STATCUP II 4 Panel CLIA Waived Test Cup, 25Pcs/Box AMP/COC/OPI/PCP

MICRO DISTRIBUTING, L.C

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

• Primary Device ID: 00816036025487
• NIH Device Record Key: f394b60a-8ebe-4ea8-8669-f1d96ef13bbd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STATCUP® II
• Version Model Number: STATII-0247-0
• Catalog Number: STATII-0247-0
• 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
• 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
• 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	00816036025470 [Primary]
GS1	00816036025487 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133968

FDA Product Code

• LCM: Enzyme Immunoassay, Phencyclidine

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: 2022-02-17
• Device Publish Date: 2022-02-09

On-Brand Devices [STATCUP® II]

• 00816036025159: STATCUP II 14 Panel Test Cup W/AD, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/PPX/TCA/THC +
• 00816036025142: STATCUP II 12 Panel Test Cup W/AD, AMP/BARB/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/TCA/THC + PH-CR-OX
• 00816036025135: STATCUP II 12 Panel Test Cup W/AD, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC + PH-CR-OX
• 00816036025128: STATCUP II 12 Panel Test Cup, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC, 25Pcs/Box
• 00816036025111: STATCUP II 10 Panel Test Cup W/AD, AMP/BAR/BZO/COC/mAMP/MOR/MTD/OXY/PCP/THC + PH-CR-OX, 25Pcs/Bo
• 00816036025104: STATCUP II 10 Panel Test Cup, AMP/BAR/BZO/COC/mAMP/MOR/MTD/OXY/PCP/THC, 25Pcs/Box
• 00816036025098: STATCUP II 10 Panel Test Cup, AMP/BAR/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC, 25Pcs/Box
• 00816036025081: STATCUP II 10 Panel Test Cup W/AD, AMP/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/THC + PH-CR-OX, 25Pcs/B
• 00816036025074: STATCUP II 8 Panel Test Cup W/AD, AMP/BZO/COC/mAMP/MOR/MTD/OXY/THC + pH-CR-OX, 25Pcs/Box
• 00816036025050: STATCUP II 6 Panel Test Cup W/AD, BZO/COC/mAMP/MOR/OXY/THC + pH-CR-OX, 25Pcs/Box
• 00816036025043: STATCUP II 6 Panel Test Cup W/AD, AMP/BZO/COC/mAMP/MOR/THC + PH-CR-OX, 25Pcs/Box
• 00816036025036: STATCUP II 6 Panel Test Cup, 25Pcs/Box AMP/BZO/COC/mAMP/MOR/THC
• 00816036025029: STATCUP II 5 Panel Test Cup, 25Pcs/Box BZO/COC/mAMP/MOR/THC
• 00816036025012: STATCUP II 5 Panel Test Cup W/AD, AMP/COC/mAMP/OPI/THC + pH-CR-OX, 25Pcs/Box
• 00816036025005: STATCUP II 5 Panel Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/THC
• 00816036021830: STAT II DOA 6 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box BZO/COC/mAMP/MOR/OXY/THC
• 00816036021816: STAT II DOA 6 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box AMP/COC/mAMP/OPI/PCP/THC + pH,CR, OX
• 00816036021793: STAT II DOA 6 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/PCP/THC
• 00816036021762: STAT II DOA 5 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/COC/MAMP/OPI/PCP
• 00816036021748: STAT II DOA 6 in 1 CLIA Waived Test Cup, 25Pcs/Box BZO/COC/EDDP/MOR/MTD/THC
• 00816036021724: STAT II DOA 10 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box AMP/BUP/BZO/COC/mAMP/MOR/MTD/MDMA/OXY/T
• 00816036021632: STAT II DOA 5 in 1 Test Cup, 25Pcs/Box BZO/COC/mAMP/MOR/THC
• 00816036021595: STAT II DOA 10 in 1 CLIA WAIVED Test Cup W/AD, 25Pcs/Box AMP/BARB/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/
• 00816036020994: STAT II DOA 14 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box AMP/BARB/BUP/BZO/COC/EDDP/mAMP/MDMA/MOR
• 00816036020987: STATCUP II, 12 Panel CLIA WAIVED Test Cup W/AD, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/T
• 00816036020970: STAT II DOA 12 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box AMP/BARB/BZO/COC/mAMP/MDMA/MOR/MTD/OXY
• 00816036020963: STAT II DOA 12 in 1 Test Cup W/AD, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/TCA/THC/P
• 00816036020956: STAT II DOA 12 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/BARB/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/T
• 00816036020949: STATCUP II, 12 Panel CLIA WAIVED Test Cup W/AD, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/T
• 00816036020932: STATCUP II, 12 Panel CLIA WAIVED Test Cup, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC, 2
• 00816036020925: STAT II DOA 10 in 1 Test Cup W/AD, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/THC/PH-SG-OX
• 00816036020918: STAT II DOA 10 in 1 Test Cup, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC
• 00816036020901: STAT II DOA 10 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MOR/MTD/OXY/PCP/TH
• 00816036020895: STAT II DOA 10 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MOR/MTD/OXY/PCP/THC
• 00816036020871: STAT II DOA 8 in 1 Test Cup W/AD, 25Pcs/Box AMP/BZO/COC/mAMP/MOR/MTD/OXY/THC + pH, CR, OX
• 00816036020840: STAT II DOA 6 in 1 Test Cup W/AD, 25Pcs/Box BZO/COC/mAMP/MOR/OXY/THC + pH - CR- OX
• 00816036020833: STAT II DOA 6 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box AMP/BZO/COC/mAMP/MOR/THC/PH-CR-OX
• 00816036020826: STAT II DOA 6 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/BZO/COC/mAMP/MOR/THC
• 00816036020819: STAT II DOA 5 in 1 Test Cup W/AD, 25Pcs/Box AMP/COC/mAMP/OPI/THC+pH,SG,OX
• 00816036020802: STAT II DOA 5 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/THC
• 00816036020796: STAT II DOA 5 in 1 CLIA Waived Test Cup, 25Pcs/Box BZO/COC/mAMP/OPI/THC
• 00816036025364: STATCUP II 5 Panel CLIA Waived Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/PCP
• 00816036025449: STATCUP II 8 Panel Test Cup W/AD, AMP/BUP/BZO/COC/mAMP/MDMA/MOR//THC, 25Pcs/Box
• 00816036025418: STATCUP II 12 Panel OTC Test Cup, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC, 1 test per
• 00816036025401: STATCUP II 6 Panel CLIA Waived Test Cup, with Adulterants 25Pcs/Box AMP/COC/mAMP/OPI/PCP/THC +pH
• 00816036025388: STATCUP II 6 Panel CLIA Waived Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/PCP/THC
• 00816036025340: STATCUP II 12 Panel CLIA Waived Test Cup W/AD, AMP/BARB/BZO/BUP/COC/EDDP/mAMP/MDMA/MOR/MTD/OXY/P
• 00816036025463: STATCUP II 10 Panel Test Cup W/AD, AMP/BAR/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/ + PH-CR-OX, 25Pcs/
• 00816036021908: STAT II DOA 4 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/COC/OPI/PCP
• 00816036025487: STATCUP II 4 Panel CLIA Waived Test Cup, 25Pcs/Box AMP/COC/OPI/PCP