FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MultiCode® BK Virus Primers
DI: 00840487101308
·
Model: 3908-21
·
LUMINEX CORPORATION
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
- MultiCode® BK Virus Primers
- Primary DI
- 00840487101308
- Version / Model
- 3908-21
- Catalog Number
- 3908-21
- Company Name
- LUMINEX CORPORATION
- Labeler DUNS
- 079686463
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-16
- Public Version
- 3
- Public Version Date
- 2021-03-03
- Public Version Status
- Update
- Public Device Record Key
- 09e2bdb7-3885-46d8-a844-2e487a7840de
- Distribution End Date
- 2021-03-02
Device Description
Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
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
- 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 |
|---|---|---|---|---|
| MVU | REAGENTS,SPECIFIC,ANALYTE | Pathology | 864.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49852 | BK virus (BKV) nucleic acid IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of nucleic acid from BK virus (BKV) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840487101308 | GS1 |
Customer Contacts
- Phone
- +1(866)327-3290
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – -15 Degrees Celsius