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Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum FDA UDI
- Generic Name
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 0066905 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 0066905 FDA UDI
- Primary DI / UDI-DI
- 10888234001577 FDA UDI
- FDA Product Code
- KSS FDA UDI
- GMDN Term
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.9050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination
Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum by Immucor, Inc. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination.
- Capture-P Ready-Screen — IMMUCOR, INC. · Class I
- Capture-P — IMMUCOR, INC. · Class I
- Capture-P Indicator Red Cells — IMMUCOR, INC. · Class I
- Capture-P Indicator Red Cells — IMMUCOR, INC. · Class I
- Capture-P — IMMUCOR, INC. · Class I
- Capture-P — IMMUCOR, INC. · Class I
- Capture-P Control set — IMMUCOR, INC. · Class I
Cleared under the same submission
BK860017 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Immucor, Inc.
Sources (1)
- FDA UDI 17362d65-312e-41f4-bb8b-43f6b7e1dc1f 35 fields · synced May 31, 2026