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Capture-R Positive Control Serum (Weak), Capture-R Negative Control Serum
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Capture-R Positive Control Serum (Weak), Capture-R Negative Control Serum FDA UDI
- Generic Name
- Total immunoglobulin G (IgG total) IVD, control FDA UDI
- Device Name
- Immucor’s Capture-R Positive Control Serum (Weak) and Capture-R Negative Control Serum are run controls to be used in Capture-R Solid Phase Assays, including Capture-R Select, Capture-R Ready-Screen and Capture-R Ready-ID. Capture-R Positive Control Serum (Weak) contains antibodies to red blood cells and sodium azide added as a preservative. Capture-R Negative Control Serum contains no antibodies to red blood cells; sodium azide is added as a preservative. FDA UDI
- Model / Reference
- 0066902 FDA UDI
- Description
- Immucor’s Capture-R Positive Control Serum (Weak) and Capture-R Negative Control Serum are run controls to be used in Capture-R Solid Phase Assays, including Capture-R Select, Capture-R Ready-Screen and Capture-R Ready-ID. Capture-R Positive Control Serum (Weak) contains antibodies to red blood cells and sodium azide added as a preservative. Capture-R Negative Control Serum contains no antibodies to red blood cells; sodium azide is added as a preservative. FDA UDI
Identifiers
- Catalog Number
- 0066902 FDA UDI
- Primary DI / UDI-DI
- 10888234001546 FDA UDI
- FDA Product Code
- KSS FDA UDI
- GMDN Term
- Total immunoglobulin G (IgG total) IVD, control 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
Yes
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: Total immunoglobulin G (IgG total) IVD, control
Capture-R Positive Control Serum (Weak), Capture-R Negative Control Serum by Immucor, Inc. — Class I — FDA UDI — listed in FDA GUDID
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Also classified as Total immunoglobulin G (IgG total) IVD, control.
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- Negative Control Mo IgG1/RPE-Cy5, Cl DAK-GO1 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class II
- IgG control slides — BIO SB, INC. · Class I
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 33b72fcc-5af1-497a-b068-bd48fe5014b6 35 fields · synced May 30, 2026