FDA UDI
In Commercial Distribution
🇺🇸 United States
Teco Diagnostics Urine Porphobilinogen (PBG) Test Kit
DI: 10673486001006
·
Model: URS-PBG-1
·
TECO DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Teco Diagnostics Urine Porphobilinogen (PBG) Test Kit
- Primary DI
- 10673486001006
- Version / Model
- URS-PBG-1
- Catalog Number
- URS-PBG-1
- Company Name
- TECO DIAGNOSTICS
- Labeler DUNS
- 185067774
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-07
- Public Version
- 1
- Public Version Date
- 2023-12-15
- Public Version Status
- New
- Public Device Record Key
- 717d06bc-29e3-4125-89fe-78f59a54d009
Device Description
Teco Diagnostics Urine Porphobilinogen (PBG) Test Kit is intended for the in vitro qualitative determination of porphobilinogen (PBG) in urine to aid in the primary screening for acute porphyria. For Professional Use only.
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| JNF | Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen | Clinical Chemistry | 862.1590 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53532 | Porphobilinogen IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of the porphyrin metabolite porphobilinogen in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10673486001006 | GS1 |
Customer Contacts
- Phone
- 7144631111
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius