FDA UDI
In Commercial Distribution
🇺🇸 United States
IHC
DI: 00810170553615
·
Model: Proteinase K
·
Slmp, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- IHC
- Primary DI
- 00810170553615
- Version / Model
- Proteinase K
- Catalog Number
- ACR-019
- Company Name
- Slmp, LLC
- Labeler DUNS
- 118544521
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-31
- Public Version
- 1
- Public Version Date
- 2025-04-08
- Public Version Status
- New
- Public Device Record Key
- 4cea6eaa-1f29-428f-a7bc-2c050d994c2c
Device Description
Proteinase K, 2 mL
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
- 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 |
|---|---|---|---|---|
| PPM | General Purpose Reagent | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57778 | Immunohistochemistry protease reagent IVD | A substance or reactant which may include proteinase K and/or pepsin intended to be used for the enzymatic retrieval of antigenic epitopes from tissue in an enzyme immunohistochemistry assay performed on biological tissues or clinical specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810170553615 | GS1 |