FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SPOT-Light® Tissue Pretreatment Kit
DI: 10190302000048
·
Model: 008401
·
LIFE TECHNOLOGIES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SPOT-Light® Tissue Pretreatment Kit
- Primary DI
- 10190302000048
- Version / Model
- 008401
- Company Name
- LIFE TECHNOLOGIES CORPORATION
- Labeler DUNS
- 080131636
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-01
- Public Version
- 4
- Public Version Date
- 2022-06-07
- Public Version Status
- Update
- Public Device Record Key
- 5de54715-7166-484c-ba8d-96803020d5e3
- Distribution End Date
- 2022-06-01
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 57770 | Immunohistochemistry antigen retrieval reagent IVD | A substance or reactant intended to be used for the non-enzymatic retrieval of antigenic epitopes from biological tissues or clinical specimen, using an enzyme immunohistochemistry assay. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10190302000048 | GS1 |