FDA UDI
In Commercial Distribution
🇺🇸 United States
Pointe Scientific, Inc.
DI: 00811727013262
·
Model: F1031-96
·
HORIBA INSTRUMENTS INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Pointe Scientific, Inc.
- Primary DI
- 00811727013262
- Version / Model
- F1031-96
- Catalog Number
- F1031-96
- Company Name
- HORIBA INSTRUMENTS INCORPORATED
- Labeler DUNS
- 052845583
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 3
- Public Version Date
- 2025-10-02
- Public Version Status
- Update
- Public Device Record Key
- 81a37ec3-4dd2-4ca6-a194-8fa497701aab
Device Description
The LH ELISA is intended for the quantitative determination of luteinizing hormone (LH) in human serum. This assay is useful in the diagnosis and treatment of gonadal dysfunction. 96 Tests.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- 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 |
|---|---|---|---|---|
| 54253 | Luteinizing hormone (LH) IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of luteinizing hormone (LH) in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811727013262 | GS1 |
Customer Contacts
- Phone
- 800-445-9853
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius