STATTEST Home Pregnancy Test STP-10-0

GUDID 00816036025968

Single STATDIP Pregnancy Midstream 10 mIU/mL, 1 Test per Box

MICRO DISTRIBUTING, L.C

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

• Primary Device ID: 00816036025968
• NIH Device Record Key: 13640463-d1d9-4172-bdb3-74d4f10f319e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STATTEST Home Pregnancy Test
• Version Model Number: STP-10-0
• Catalog Number: STP-10-0
• Company DUNS: 087732173
• Company Name: MICRO DISTRIBUTING, L.C
• Device Count: 1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816036025968 [Primary]

FDA Product Code

• LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-07-06
• Device Publish Date: 2020-06-18

Devices Manufactured by MICRO DISTRIBUTING, L.C

• 00816036025494 - STATCUP®: 2023-08-02 STATCUP 9 Panel Test Cup w/Adulterants, AMP/BAR/BZO/COC/mAMP/MOR/MTD/PCP/THC + CR,OX,pH , 25Pcs/Box
• 00816036025968 - STATTEST Home Pregnancy Test: 2023-07-06Single STATDIP Pregnancy Midstream 10 mIU/mL, 1 Test per Box
• 00816036025968 - STATTEST Home Pregnancy Test: 2023-07-06 Single STATDIP Pregnancy Midstream 10 mIU/mL, 1 Test per Box
• 00816036027177 - STATCUP®: 2022-04-01 STATCUP 10 Panel Test Cup, AMP/BAR/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC + CR,OX,pH , 25Pcs/Box
• 00816036021960 - STATDIP®: 2022-03-22 STAT DOA 10 in 1 CLIA Waived Test Dipcard, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MTD/OPI/PCP/PPX/THC
• 00816036025487 - STATCUP® II: 2022-02-17 STATCUP II 4 Panel CLIA Waived Test Cup, 25Pcs/Box AMP/COC/OPI/PCP
• 00816036021694 - STATCUP®: 2021-12-15 STAT DOA 10 in 1 Test Cup W/AD, 25Pcs/Box AMP/BAR/BUP/BZO/COC/mAMP/MOR/MTD/OXY/THC/PH-SG-OX
• 00816036021625 - STATCUP®: 2021-12-09 STAT DOA 10 in 1 Test Cup W/AD, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MTD/OPI/PCP//PPX/THC/
• 00816036021649 - STATCUP®: 2021-12-09 STAT DOA 12 in 1 Test Cup W/AD, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MOR/MTD/MDMA/OXY/PCP/THC/PPX/PH-SG-OX