FDA UDI
Not in Commercial Distribution
🇺🇸 United States
co-innovation
DI: 06970429844117
·
Model: LH TEST
·
Co-Innovation Biotech Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- co-innovation
- Primary DI
- 06970429844117
- Version / Model
- LH 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
- 2025-10-20
- Public Version
- 1
- Public Version Date
- 2025-10-28
- Public Version Status
- New
- Public Device Record Key
- ecf2aa32-36d1-4515-9bce-a44fda8adb58
- Distribution End Date
- 2025-10-20
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | Clinical Chemistry | 862.1485 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54255 | Luteinizing hormone (LH) 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 luteinizing hormone (LH) 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. 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 | 16970429844114 | GS1 | 20 | Not in Commercial Distribution | 2025-10-20 | |
| Primary | 06970429844117 | GS1 | ||||
| Package | 26970429844111 | GS1 | 25 | Not in Commercial Distribution | 2025-10-20 | |
| Package | 36970429844118 | GS1 | 50 | Not in Commercial Distribution | 2025-10-20 | |
| Package | 46970429844115 | GS1 | 100 | Not in Commercial Distribution | 2025-10-20 |