FDA UDI
In Commercial Distribution
🇺🇸 United States
Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum
DI: 10888234001577
·
Model: 0066905
·
IMMUCOR, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum
- Primary DI
- 10888234001577
- Version / Model
- 0066905
- Catalog Number
- 0066905
- Company Name
- IMMUCOR, INC.
- Labeler DUNS
- 061446282
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-03
- Public Version
- 1
- Public Version Date
- 2022-09-12
- Public Version Status
- New
- Public Device Record Key
- 17362d65-312e-41f4-bb8b-43f6b7e1dc1f
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.
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| KSS | Supplies, Blood-Bank | Hematology | 864.9050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56576 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888234001577 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK860017 | 0 |