co-innovation

GUDID 16970429840178

Co-Innovation Biotech Co., Ltd

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

• Primary Device ID: 16970429840178
• NIH Device Record Key: c20dfc8e-50e7-4a4d-9163-164baa8cd9f1
• Commercial Distribution Discontinuation: 2023-04-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: co-innovation
• Version Model Number: HCG TEST
• Company DUNS: 421302978
• Company Name: Co-Innovation Biotech Co., Ltd
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970429840171 [Primary]
GS1	16970429840178 [Package]; Contains: 06970429840171; Package: [3 Units]; Discontinued: 2023-04-28; Not in Commercial Distribution
GS1	26970429840175 [Package]; Contains: 06970429840171; Package: [10 Units]; Discontinued: 2023-04-28; Not in Commercial Distribution
GS1	36970429840172 [Package]; Contains: 06970429840171; Package: [20 Units]; Discontinued: 2023-04-28; Not in Commercial Distribution
GS1	46970429840179 [Package]; Contains: 06970429840171; Package: [25 Units]; Discontinued: 2023-04-28; Not in Commercial Distribution
GS1	56970429840176 [Package]; Contains: 06970429840171; Package: [30 Units]; Discontinued: 2023-04-28; Not in Commercial Distribution
GS1	66970429840173 [Package]; Contains: 06970429840171; Package: [50 Units]; Discontinued: 2023-04-28; Not in Commercial Distribution
GS1	76970429840170 [Package]; Contains: 06970429840171; Package: [100 Units]; Discontinued: 2023-04-28; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213808

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-08
• Device Publish Date: 2023-04-28

On-Brand Devices [co-innovation]

• 06970429841420: 14P DRUG TEST CUP
• 16970429841410: 14P Rapid Multi-Drug Test Cup
• 26970429841288: 12P drug test cup
• 36970429841278: 12P Drug Test Dipcard
• 36970429841261: 12P DRUG TEST DIPCARD
• 16970429841250: 12P Rapid Multi-Drug Test Cup
• 26970429841110: Rapid Multi drug Test Cup 11 Pannel
• 16970429840710: 7P Rapid Multi-Drug Test Cup
• 16970429840635: Rapid ETG Test Dipcard
• 36970429840622: 6P Drug Test Dipcard
• 06970429840539: Rapid THC Test Dipcard
• 06970429840614: THC Strip/3.0mm
• 06970429840423: OPI Test Strip
• 06970429840317: 3P Drug Test Dipcard
• 06970429840416: HCG Cassette
• 06970429840218: HCG Strip/4.0mm
• 16970429841618: 16P CUP
• 16970429841908: 12P Drug Test
• 16970429841809: 18P Drug Test
• 16970429841700: 17P Drug Test
• 16970429841625: 16P Drug Test
• 16970429841533: 15P Drug Test
• 16970429841441: 14P Drug Test
• 16970429841816: Rapid Multi-drug Test Cup
• 16970429840178: HCG TEST
• 16970429843315: FYL TEST