FDA UDI
In Commercial Distribution
🇺🇸 United States
FluoroQuench Plus Acridine Orange/Ethidium Bromide - 100 ml
DI: 00812117018447
·
Model: N/A
·
ONE LAMBDA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FluoroQuench Plus Acridine Orange/Ethidium Bromide - 100 ml
- Primary DI
- 00812117018447
- Version / Model
- N/A
- Catalog Number
- FQZAE100
- Company Name
- ONE LAMBDA, INC.
- Labeler DUNS
- 118289289
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-31
- Public Version
- 1
- Public Version Date
- 2018-07-02
- Public Version Status
- New
- Public Device Record Key
- 2de68b19-e6df-4cea-aadc-9a09ad7c05c4
Device Description
FluoroQuench products are used to fluorescently stain and fix lymphocytes in the microcytotoxicity assays.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KQC | Stains, Hematology | Hematology | 864.1850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15599 | Microscope slide stainer IVD | An automated mains electricity (AC-powered) laboratory instrument intended to be used to stain blood, tissue and/or other clinical specimens fixed to microscope examination slides, using one or more biological or cytochemical staining solutions in preparation for subsequent microscopic analysis. The device operates with minimal technician involvement and complete automation of all procedural steps. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812117018447 | GS1 |
Customer Contacts
- Phone
- 800.822.8824
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 5 Degrees Celsius