FDA UDI
Not in Commercial Distribution
🇺🇸 United States
co-innovation
DI: 06970429840171
·
Model: HCG TEST
·
Co-Innovation Biotech Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
8
Pkg Device Count
1
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Basic Information
- Brand Name
- co-innovation
- Primary DI
- 06970429840171
- Version / Model
- HCG TEST
- Company Name
- Co-Innovation Biotech Co., Ltd
- Labeler DUNS
- 421302978
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-28
- Public Version
- 4
- Public Version Date
- 2026-04-13
- Public Version Status
- Update
- Public Device Record Key
- c20dfc8e-50e7-4a4d-9163-164baa8cd9f1
- Distribution End Date
- 2023-04-28
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Clinical Chemistry | 862.1155 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33819 | Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to aid detection of pregnancy, or as a predictor of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome). It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16970429840178 | GS1 | 3 | Not in Commercial Distribution | 2023-04-28 | |
| Primary | 06970429840171 | GS1 | ||||
| Package | 26970429840175 | GS1 | 10 | Not in Commercial Distribution | 2023-04-28 | |
| Package | 36970429840172 | GS1 | 20 | Not in Commercial Distribution | 2023-04-28 | |
| Package | 46970429840179 | GS1 | 25 | Not in Commercial Distribution | 2023-04-28 | |
| Package | 56970429840176 | GS1 | 30 | Not in Commercial Distribution | 2023-04-28 | |
| Package | 66970429840173 | GS1 | 50 | Not in Commercial Distribution | 2023-04-28 | |
| Package | 76970429840170 | GS1 | 100 | Not in Commercial Distribution | 2023-04-28 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213808 | 000 |