FDA UDI
In Commercial Distribution
🇺🇸 United States
Teco Diagnostics Rheumatoid Factor (RF) Reagent Set
DI: 10673486002423
·
Model: RF-100
·
TECO DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Teco Diagnostics Rheumatoid Factor (RF) Reagent Set
- Primary DI
- 10673486002423
- Version / Model
- RF-100
- Catalog Number
- RF-100
- Company Name
- TECO DIAGNOSTICS
- Labeler DUNS
- 185067774
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-01
- Public Version
- 1
- Public Version Date
- 2024-04-09
- Public Version Status
- New
- Public Device Record Key
- f529d89f-77f1-4807-866b-728bee1345ae
Device Description
Teco Diagnostics Rheumatoid Factor (RF) Reagent Set is for the qualitative and semi-quantitative measurement of RF in human serum.
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
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DHR | System, Test, Rheumatoid Factor | Immunology | 866.5775 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55112 | Rheumatoid factor IVD, kit, agglutination | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of rheumatoid factor immunoglobulins in a clinical specimen, using an agglutination method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10673486002423 | GS1 |
Customer Contacts
- Phone
- 7144631111
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K962015 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius