FDA UDI
In Commercial Distribution
🇺🇸 United States
Teco Diagnostics Vaginal pH Screening Kit
DI: 10673486001037
·
Model: MRS-OBGYN-VPH
·
TECO DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Teco Diagnostics Vaginal pH Screening Kit
- Primary DI
- 10673486001037
- Version / Model
- MRS-OBGYN-VPH
- Catalog Number
- MRS-OBGYN-VPH
- Company Name
- TECO DIAGNOSTICS
- Labeler DUNS
- 185067774
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-03
- Public Version
- 1
- Public Version Date
- 2023-11-13
- Public Version Status
- New
- Public Device Record Key
- e6b1b4b4-0e27-4ea3-bc6d-b3fd578570a7
Device Description
Teco Diagnostics Vaginal pH Screening Kit is an easy, single-use device designed for testing pH in the vagina.
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
- 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 |
|---|---|---|---|---|
| LNW | Paper, Obstetric Ph | Clinical Chemistry | 862.1550 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58011 | Vaginal pH screening IVD, kit, rapid colorimetric, self-testing | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi)-quantitative screening of vaginal secretions to determine pH range, within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment to assess for pH imbalance resulting from potential bacterial or parasitic infection. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10673486001037 | GS1 |
Customer Contacts
- Phone
- 7144631111
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius