Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum
- Primary DI
- 10888234001577
- Brand
- Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum
- Company
- IMMUCOR, INC.
- Model
- 0066905
- Catalog number
- 0066905
- Device description
- Immucor’s Capture-P Positive Control Serum (Weak) and Capture-P Negative Control Serum are run controls to be used in the Capture-P and Capture-P Ready-Screen Solid Phase assays.
- Published
- 2022-09-03
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| KSS | Supplies, Blood-Bank |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| KSS | Supplies, Blood-Bank | Hematology | 1 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| BK860017 | 0 |
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| BK860017 | 0 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10888234001577 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10888234001577 | 10888234001577 |
GMDN Terms#
| Term | Definition |
|---|---|
| Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination | A collection of reagents and other associated materials intended to be used in screening and/or identification of one or multiple antibodies to human platelet antigen (HPA) systems, which may include HPA-1, HPA-2, HPA-3, HPA-4, HPA-5 and/or HPA-15, in a clinical specimen using an agglutination method. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 061446282
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10888234002291 | Capture LISS | 0066908 | 0066908 | 2022-09-03 |
| 10888234001027 | H.P.C. (Human Platelet Concentrate) | 0057320 | 0057320 | 2016-04-18 |
| 10888234002475 | ImmuLINK | 0030311 | 2024-12-05 | |
| 10888234000495 | Red Blood Cell (RBC) Storage Solution | 0005036 | 0005036 | 2016-04-15 |
| 10888234001065 | Specimen Diluent | 0066052 | 0066052 | 2016-04-18 |
| 10888234001072 | Specimen Diluent | 0066053 | 0066053 | 2016-04-18 |
| 10888234001041 | Galileo Neo | 0064599 | 0064599 | 2016-04-18 |
| 10888234001584 | Galileo Echo | 0087000 | 0087000 | 2016-04-18 |
| 10888234001591 | CMT Plates | 0089000 | 0089000 | 2016-04-18 |
| 10888234002321 | NEO Iris | 0064597 | 0064597 | 2018-12-10 |
| 10888234002338 | Echo Lumena | 0086998 | 0086998 | 2018-06-01 |
| 10888234001546 | Capture-R Positive Control Serum (Weak), Capture-R Negative Control Serum | 0066902 | 0066902 | 2022-09-03 |
| 10888234001553 | Capture-R Select | 0066903 | 0066903 | 2022-09-03 |
| 10888234001560 | Capture-P | 0066904 | 0066904 | 2022-09-03 |
| 10888234002307 | Capture-R Ready Indicator Red Cells | 0066907 | 0066907 | 2022-09-03 |
| 10888234002314 | Capture-P Indicator Red Cells | 0066906 | 0066906 | 2022-09-03 |
| 10888234001522 | Referencells | 0066900 | 0066900 | 2022-08-03 |
| 10888234001539 | Capture-R Ready-Screen 3 | 0066901 | 0066901 | 2022-08-01 |
| 10888234002239 | Gamma-Clone Anti-Fya (Monoclonal) Blood Grouping Reagent | 10 mL size vial / 5mL fill volume | 0066430 | 2022-04-22 |
| 10888234002420 | Anti-s (Monoclonal) Gamma-clone | 0066429 | 0066429 | 2022-04-22 |
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