Identity
- Trade Name
- Pointe Scientific, Inc. Rubella IgM FDA UDI
- Generic Name
- Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Pointe Scientific, Inc. Rubella IgM is for the qualitative detection of human IgM antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the diagnosis of rubella infection. A positive result is presumptive for the detection of anti-rubella IgM antibodies and presumptive for the diagnosis of acute or recent rubella infection. 96 tests FDA UDI
- Model / Reference
- T8004-96 FDA UDI
- Description
- Pointe Scientific, Inc. Rubella IgM is for the qualitative detection of human IgM antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the diagnosis of rubella infection. A positive result is presumptive for the detection of anti-rubella IgM antibodies and presumptive for the diagnosis of acute or recent rubella infection. 96 tests FDA UDI
Identifiers
- Catalog Number
- T8004-96 FDA UDI
- Primary DI / UDI-DI
- 00811727015181 FDA UDI
- 510(k) Number
- K982281 FDA UDI
- FDA Product Code
- LFX FDA UDI
- GMDN Term
- Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3510 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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: Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Pointe Scientific, Inc. Rubella IgM by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Bio-Rad Laboratories, Inc. — Bio-Rad Laboratories · Class II
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- ASI Rubella IgM EIA Test — Arlington Scientific, Inc. · Class II
- ReQuest — QUEST INTERNATIONAL, INC. · Class II
- ELISA Rubella IgM Test System — ZEUS SCIENTIFIC, INC.
Cleared under the same submission
K982281 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 II | Pending data |
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Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 91ced107-d392-4070-a893-0ae36de437db 37 fields · synced May 30, 2026