FDA UDI
In Commercial Distribution
🇺🇸 United States
FITC TdT Reagent
DI: B7826100C02
·
Model: 6100C
·
Supertechs, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- FITC TdT Reagent
- Primary DI
- B7826100C02
- Version / Model
- 6100C
- Catalog Number
- 6100C
- Company Name
- Supertechs, Inc.
- Labeler DUNS
- 071245690
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-08
- Public Version
- 2
- Public Version Date
- 2023-11-15
- Public Version Status
- Update
- Public Device Record Key
- 37dbc73c-6e41-4d52-b148-2d3aca9d4249
Device Description
Analyte Specific Reagent FITC conjugated mouse anti-human TdT 4 clone mix (2 IgG1 & 2 IgG2a)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MVU | Reagents, Specific, Analyte | Pathology | 864.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54700 | Terminal deoxynucleotidyl transferase (TdT) 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 terminal deoxynucleotidyl transferase (TdT) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B7826100C02 | HIBCC |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid exposure to light
- Type
- Storage Environment Temperature
- Temperature Range
- – -20 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius