FlowPRA™ HLA Class I & II Beads - Sample
- Primary DI
- 00812117018140
- Brand
- FlowPRA™ HLA Class I & II Beads - Sample
- Company
- ONE LAMBDA, INC.
- Model
- N/A
- Catalog number
- FL1260SAM
- Device description
- The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
- Published
- 2016-08-11
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00812117018140 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00812117018140 | 00812117018140 | 812117018140 | 0812117018140 |
GMDN Terms
| Term | Definition |
|---|
| HLA class I & II antibody screening IVD, kit, multiplex | A collection of reagents and other associated materials intended to be used in screening for one or multiple antibodies to HLA class I and II antigens in a clinical specimen, using solid phase antigens together with a multiplex method. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | -80 Degrees Celsius | -65 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 118289289
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00812117015484 | PE-Conjugated Streptavidin | N/A | LSPSAB2 | 2020-06-04 |
| 00812117010199 | LABScreen™ Single Antigen HLA Class I ExPlex | N/A | LS1AEX01 | 2020-06-03 |
| 00812117014654 | LABScreen™ Single Antigen HLA Class II ExPlex | N/A | LS2AEX01 | 2020-06-03 |
| 00814695022496 | UniMatch™ Plus Software | N/A | 790111 | 2016-08-31 |
| 00812117015255 | Adsorb Out | N/A | ADSORB | 2018-06-15 |
| 00814695024452 | Micro SSP™ Gel System - 108 Wells | N/A | MGS108 | 2018-06-15 |
| 00812117015873 | Fluorobeads™ T Lymphocyte – 25 Isolations | N/A | FB1-25 | 2018-05-31 |
| 00812117015880 | Fluorobeads™ B Lymphocyte – 25 Isolations | N/A | FB2-25 | 2018-05-31 |
| 00812117015897 | FluoroQuench Acridine Orange/Ethidium Bromide - 100ml | N/A | FQAE100 | 2018-05-31 |
| 00812117016184 | FluoroQuench Acridine Orange/Ethidium Bromide - 500ml | N/A | FQAE500 | 2018-05-31 |
| 00812117016207 | FluoroQuench Acridine Orange/Ethidium Bromide - 2000 ml | N/A | FQAE2000 | 2018-05-31 |
| 00812117016832 | Lympho-Kwik T/B Lymphocyte, 25 isolations | N/A | LKTB25 | 2018-05-31 |
| 00812117018041 | Fluorobeads™ T Lymphocyte – 100 Isolations | N/A | FB1-100 | 2018-05-31 |
| 00812117018058 | FluoroBeads™ T Developer (10X) | N/A | FB1-DEV | 2018-05-31 |
| 00812117018072 | Fluorobeads™ B Lymphocyte – 100 Isolations | N/A | FB2-100 | 2018-05-31 |
| 00812117018447 | FluoroQuench Plus Acridine Orange/Ethidium Bromide - 100 ml | N/A | FQZAE100 | 2018-05-31 |
| 00812117018768 | Lympho-Kwik Mononuclear Cell, 50 isolations | N/A | LK-50-MN | 2018-05-31 |
| 00812117018775 | Lympho-Kwik T Lymphocyte, 50 isolations | N/A | LK-50-T | 2018-05-31 |
| 00812117018782 | Lympho-Kwik T/B Lymphocyte, 50 isolations | N/A | LK-50-TB | 2018-05-31 |
| 00812117018799 | Lympho-Kwik T Lymphocyte, 25 isolations | N/A | LKT25 | 2018-05-31 |
onelambda.com