Identity
- Trade Name
- CARDINAL HEALTH FDA UDI
- Generic Name
- Rubella virus total antibody IVD, kit, rapid agglutination, clinical FDA UDI
- Device Name
- SP Rubella Test 30 Determination FDA UDI
- Model / Reference
- B1077-16 FDA UDI
- Description
- SP Rubella Test 30 Determination FDA UDI
Identifiers
- Catalog Number
- B1077-16 FDA UDI
- Primary DI / UDI-DI
- 20885380020183 FDA UDI
- 510(k) Number
- K031490 FDA UDI
- FDA Product Code
- LQN FDA UDI
- GMDN Term
- Rubella virus total antibody IVD, kit, rapid agglutination, clinical 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rubella virus total antibody IVD, kit, rapid agglutination, clinical
Cardinal Health by Cardinal Health 200, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rubella virus total antibody IVD, kit, rapid agglutination, clinical.
- ASI Rubella Test — Arlington Scientific, Inc. · Class II
- ASI Rubella Test — Arlington Scientific, Inc.
- Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
- Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
- ASI Rubella Test — Arlington Scientific, Inc. · Class II
- ASI Rubella Test — Arlington Scientific, Inc. · Class II
- Aero-Med — AERO-MED LLC · Class I
- Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
Cleared under the same submission
K031490 also covers:
- ASI Rubella Test — Arlington Scientific, Inc.
- ASI Rubella Test — Arlington Scientific, Inc.
- ASI Rubella Test — Arlington Scientific, Inc.
- ASI Rubella Test — Arlington Scientific, Inc.
- ASI Rubella Test — Arlington Scientific, Inc.
- ASI Rubella Test — Arlington Scientific, Inc.
- ASI Rubella Test Control Set — Arlington Scientific, Inc.
- CARDINAL HEALTH — Cardinal Health 200, LLC
- CARDINAL HEALTH — Cardinal Health 200, LLC
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
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI c35394c5-1c9f-40a5-8498-e5f05a99f050 36 fields · synced Jun 8, 2026