FDA UDI
In Commercial Distribution
🇺🇸 United States
N FLC SUPPLEMENTARY REAGENT
DI: 00630414237473
·
Model: 10873660
·
Siemens Healthcare Diagnostics Products GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- N FLC SUPPLEMENTARY REAGENT
- Primary DI
- 00630414237473
- Version / Model
- 10873660
- Catalog Number
- OPJC05
- Company Name
- Siemens Healthcare Diagnostics Products GmbH
- Labeler DUNS
- 388240673
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-08
- Public Version
- 4
- Public Version Date
- 2021-11-18
- Public Version Status
- Update
- Public Device Record Key
- 729b6166-9d6d-46a8-b9a2-79d3f315b8c3
Device Description
Immunonephelometric determination of free light chains (FLC) type kappa and type lambda on BN Systems.
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 |
|---|---|---|---|---|
| DFH | KAPPA, ANTIGEN, ANTISERUM, CONTROL | Immunology | 866.5550 | 2 |
| DEH | LAMBDA, ANTIGEN, ANTISERUM, CONTROL | Immunology | 866.5550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53801 | Kappa/lambda light chain immunoglobulin 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 quantitative measurement of kappa and/or lambda light chain immunoglobulins in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00630414237473 | GS1 |
Customer Contacts
- Phone
- +1(800)664-3822
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171742 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius