Identity
- Trade Name
- Baha FDA UDI
- Generic Name
- Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, control FDA UDI
- Device Name
- Osscora Surgical Set 230 V (Asia Pacific) FDA UDI
- Model / Reference
- 91052 FDA UDI
- Description
- Osscora Surgical Set 230 V (Asia Pacific) FDA UDI
Identifiers
- Catalog Number
- 91052 FDA UDI
- Primary DI / UDI-DI
- 09321502038379 FDA UDI
- FDA Product Code
- GEY FDA UDI
- GMDN Term
- Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, control
Baha by Cochlear Bone Anchored Solutions AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- PreciControl Toxo IgM — Roche Diagnostics Corp. · Class I
- BioPlex 2200 — Bio-Rad Laboratories · 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
- Cochlear Bone Anchored Solutions AB
Sources (1)
- FDA UDI 914944f1-8256-4dae-b168-590fb6fea411 36 fields · synced May 30, 2026