PlasmaRef ARL-2
- Primary DI
- 10859394006184
- Brand
- PlasmaRef ARL-2
- Company
- R 2 DIAGNOSTICS, INC.
- Model
- 35-201
- Catalog number
- 35-201
- Device description
- Assayed Reference Plasma L-2 10 x 1 ml
- Published
- 2016-11-15
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| GGN | Plasma, Coagulation Control |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| GGN | Plasma, Coagulation Control | Hematology | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10859394006184 | Primary | GS1 | 0 | |
| 00859394006187 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10859394006184 | 10859394006184 | ||
| 00859394006187 | 00859394006187 | 859394006187 | 0859394006187 |
GMDN Terms#
| Term | Definition |
|---|---|
| Plasma protein IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of plasma proteins in a clinical specimen. |
Regulatory Flags#
- DUNS number
- 956610125
- Device count
- 10
- Premarket exempt
- true
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10859394006061 | PlasmaCon N | 30-201 | 30-201 | 2016-11-15 |
| 10859394006078 | PlasmaCon L1 | 31-201 | 31-201 | 2016-11-15 |
| 10859394006085 | PlasmaCon L2 | 32-201 | 32-201 | 2016-11-15 |
| 10859394006122 | PlasmaCon LA | 150-200 | 150-200 | 2016-11-15 |
| 10859394006139 | PlasmaCon LA | 150-201 | 150-201 | 2016-11-15 |
| 10859394006016 | Phospholin ES w/ Calcium Chloride | 21-410 | 21-410 | 2016-11-15 |
| 10859394006023 | Phosphoplastin RL | 11-305 | 11-305 | 2016-11-15 |
| 10859394006030 | Phosphoplastin RL | 11-310 | 11-310 | 2016-11-15 |
| 10859394006054 | T-tek | 50-201 | 50-201 | 2016-11-15 |
| 10859394006108 | LupoTek Detectin VL | 85-202 | 85-202 | 2016-11-15 |
| 10859394006115 | LupoTek Correctin VL | 86-201 | 86-201 | 2016-11-15 |
| 10859394006146 | LupoTek KCT | 87-305 | 87-305 | 2016-11-15 |
| 10859394006153 | NoFact VIII | 68-201 | 68-201 | 2016-11-15 |
| 10859394006160 | NoFact IX | 69-201 | 69-201 | 2016-11-15 |
| 10859394006191 | FIB Calibrator | 71-201 | 71-201 | 2016-11-15 |
| 10859394006238 | Phospholin ES w/Calcium | 21-405 | 21-405 | 2016-11-15 |
| 00859394006040 | Fibrotek | 70-410 | 70-410 | 2016-11-15 |
| 00859394006095 | ThromboTek PSe | 90-480 | 90-480 | 2016-11-15 |
| 10859394006177 | PlasmaRef ARN | 33-201 | 33-201 | 2016-11-15 |
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