FDA UDI
In Commercial Distribution
🇺🇸 United States
Titan Prime Universal HRP Polymer Detection Kit with DAB
DI: 00850042030097
·
Model: 1
·
Lumatas Biosystems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Titan Prime Universal HRP Polymer Detection Kit with DAB
- Primary DI
- 00850042030097
- Version / Model
- 1
- Company Name
- Lumatas Biosystems, Inc.
- Labeler DUNS
- 080169635
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-25
- Public Version
- 1
- Public Version Date
- 2023-11-02
- Public Version Status
- New
- Public Device Record Key
- 0693813f-4c03-42fa-8df0-f028e64a4b15
Device Description
A Detection System Kit containing four components. Polymer based detection system used in conjunction with DAB chromogen to allow for visualization of the tissue sample.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NJT | Immunohistochemistry Reagents And Kits | Hematology | 864.1860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57771 | Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry | A collection of reagents and other associated materials intended to be used for the discrete visualisation of immune complexes bound to specific cellular markers in a clinical specimen. Sustrates are used to detect immunoperoxidase-bound complexes and may include diaminobenzidine (DAB), aminoethylcarbazole (AEC), nitro blue tetrazolium/bromochloroindolyl phosphate (NBT/BCIP) and/or fast red using an enzyme immunohistochemistry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850042030097 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius