FDA UDI
In Commercial Distribution
🇺🇸 United States
Healgen
DI: 00816490021780
·
Model: GALH-101a
·
Healgen Scientific Limited Liability Company
Product Codes
0
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Healgen
- Primary DI
- 00816490021780
- Version / Model
- GALH-101a
- Catalog Number
- GALH-101a
- Company Name
- Healgen Scientific Limited Liability Company
- Labeler DUNS
- 031802328
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-09
- Public Version
- 3
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 94550d6f-cc22-4af7-ad49-b291a6ca0d1b
Device Description
LH Ovulation Rapid Test Strip(Urine,25mIU/mL)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
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 | 20816490021784 | GS1 | Case | 50 | In Commercial Distribution | |
| Package | 10816490021787 | GS1 | Inner Pack | 100 | In Commercial Distribution | |
| Primary | 00816490021780 | GS1 |
Customer Contacts
- Phone
- 7137338088
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius