FDA UDI
In Commercial Distribution
🇺🇸 United States
Simultag™ HLA-B27 Fluorescein Isothiocyanate / CD3 R-Phycoerythrin Monoclonal An
DI: 00812117015545
·
Model: N/A
·
ONE LAMBDA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Simultag™ HLA-B27 Fluorescein Isothiocyanate / CD3 R-Phycoerythrin Monoclonal An
- Primary DI
- 00812117015545
- Version / Model
- N/A
- Catalog Number
- 27FC3P50
- Company Name
- ONE LAMBDA, INC.
- Labeler DUNS
- 118289289
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-11
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 44639271-6405-4ac5-8346-b61809658929
Device Description
These purified monoclonal antibodies are intended for in vitro diagnostic or research use in a qualitative, whole blood procedure for direct immunofluorescence staining of HLA-B27 or other lymphocyte surface antigens with analysis by flow cytometry.
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
- No
- 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 |
|---|---|---|---|---|
| MZI | Test,Qualitative,For Hla,Non-Diagnostic | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56398 | HLA class I & II antigen tissue typing IVD, kit, multiplex | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple HLA class I and II antigens in a clinical specimen, using a multiplex method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812117015545 | GS1 |
Customer Contacts
- Phone
- 800.822.8824
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 5 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dark