Parasite Suspensions
EUDAMEDFDA UDIClass B (EU MDR)
Identity
- Trade Name
- Parasite Suspensions FDA UDI
- Generic Name
- Multiple faecal parasite antigen IVD, control FDA UDI
- Device Name
- Parasite Suspensions EUDAMEDParasite Suspensions Giardia lamblia FDA UDI
- Model / Reference
- FP01 EUDAMEDFDA UDI[FP01] Parasite Suspensions Giardia lamblia EUDAMED
- Description
- Parasite Suspensions Giardia lamblia FDA UDI
Identifiers
- Catalog Number
- FP01 FDA UDI
- Primary DI / UDI-DI
- 10845357035063 EUDAMEDFDA UDI
- Basic UDI-DI
- 08453570FP01J4 EUDAMED
- FDA Product Code
- LIB FDA UDI
- EMDN Code
- W01040699 CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER EUDAMED
- GMDN Term
- Multiple faecal parasite antigen IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2660 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
Yes
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Multiple bacteria species culture isolate identification control IVD, kit
Parasite Suspensions by Microbiologics, Inc. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple bacteria species culture isolate identification control IVD, kit.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 08453570FP01J4 | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Microbiologics, INC.
- EUDAMED SRN
- US-MF-000000466
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED c0fc9250-f971-4e9a-94b1-c5c8812436fb 61 fields · synced Jun 19, 2026
- FDA UDI 08c0d9cf-c74c-4de1-bd4e-8dc3bb722509 36 fields · synced May 30, 2026