FDA UDI
In Commercial Distribution
🇺🇸 United States
VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail
DI: 07613336160541
·
Model: 08507015001
·
Ventana Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail
- Primary DI
- 07613336160541
- Version / Model
- 08507015001
- Catalog Number
- 08507015001
- Company Name
- Ventana Medical Systems, Inc.
- Labeler DUNS
- 184042521
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-20
- Public Version
- 2
- Public Version Date
- 2025-07-08
- Public Version Status
- Update
- Public Device Record Key
- 3b3141ce-ed35-4ba9-a5a4-97ef80123372
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| SDP | Kappa and Lambda immunoglobulin light chain in situ hybridization mRNA probe detection kit | Hematology | 864.1861 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57320 | Kappa/lambda light chain messenger RNA IVD, probe | A defined piece of single-stranded nucleic acid which is used to identify specific complementary-sequence nucleic acid molecules in an assay intended to be used for the qualitative and/or quantitative detection of kappa and/or lambda light chain messenger RNA in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613336160541 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN240025 | 000 |