Identity
- Trade Name
- Rubagen 100 TESTS FDA UDI
- Generic Name
- Rubella virus total antibody IVD, kit, rapid agglutination, clinical FDA UDI
- Device Name
- 1 x 1.7 ml LATEX REAGENT 1 x 1.0 ml HIGH POSITIVE CONTROL 1 x 1.0 ml LOW POSITIVE CONTROL 1 x 1.0 ml NEGATIVE CONTROL 1 x 35 ml DILUENT BUFFER 8 disposable slides 120 plastic stirrers FDA UDI
- Model / Reference
- 300024001 FDA UDI
- Description
- 1 x 1.7 ml LATEX REAGENT 1 x 1.0 ml HIGH POSITIVE CONTROL 1 x 1.0 ml LOW POSITIVE CONTROL 1 x 1.0 ml NEGATIVE CONTROL 1 x 35 ml DILUENT BUFFER 8 disposable slides 120 plastic stirrers FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950590569 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
- Not 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
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
Rubagen 100 TESTS by Biokit, S.a. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Biokit, S.a.
Sources (1)
- FDA UDI 42a54890-d4c2-4a08-b181-626dabfa4b2a 36 fields · synced May 30, 2026