hCG Enhanced Sensitivity Rapid Test Midstream 10 mIU/mL

GUDID 00853691007694

Pregnancy (hCG) Enhanced Sensitivity Rapid Test Midstream 10 mIu/mL

ACRO BIOTECH INC

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00853691007694
• NIH Device Record Key: c3b7269f-8bef-4e0e-96fb-454501c49a28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: hCG Enhanced Sensitivity Rapid Test Midstream 10 mIU/mL
• Version Model Number: 1
• Company DUNS: 079697380
• Company Name: ACRO BIOTECH INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853691007694 [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: 2018-03-29
• Device Publish Date: 2017-07-06

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• 00853691007168 - THC Rapid Test Cassette: 2018-03-29 THC Rapid Test Cassette
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• 00853691007229 - hCG Enhanced Sensitivity Rapid Test Cassette 10 mIU/mL: 2018-03-29 hCG Enhanced Sensitivity Rapid Test Cassette 10 mIU/mL
• 00853691007595 - FOB Rapid Test Cassette: 2018-03-29 FOB Rapid Test Cassette