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Sign in to claim this brandWhat ALIFAX SRL makes
Alifax SRL manufactures in-vitro diagnostics (IVDs) for laboratory use, including erythrocyte sedimentation rate (ESR) analysers, controls, and calibrators, as well as urine analysers for screening and basic microbial testing. Their portfolio also includes nutrient broth and agar culture media for antimicrobial susceptibility testing and microbial identification, alongside optical instrument performance standards for laboratory equipment.
All listed devices fall under Class I regulatory classification in the US, with product identifiers registered in the FDA Unique Device Identifier (UDI) database. The company is based in the United States and adheres to US regulatory requirements for in-vitro diagnostics.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Alifax SRL manufacture?
Alifax SRL specialises in in-vitro diagnostics (IVDs) designed for laboratory use. Their product range includes erythrocyte sedimentation rate (ESR) analysers, along with related controls and calibrators for testing blood samples. They also produce urine analysers for screening purposes, as well as culture media—such as nutrient broth and antimicrobial testing agar—for microbial identification and susceptibility testing. Additionally, they offer optical instrument performance standards to help calibrate laboratory equipment.
Where is Alifax SRL based, and what regulatory framework does it follow?
Alifax SRL is based in the United States. Since their devices are in-vitro diagnostics, they must comply with US regulatory requirements, including those set by the FDA. Their products are listed in the FDA’s Unique Device Identifier (UDI) database, which helps track and identify medical devices under US regulations.
Which regulatory registries or databases list Alifax SRL’s devices?
Alifax SRL’s devices are registered in the FDA’s Unique Device Identifier (UDI) database. This database is used to track and identify medical devices authorised for use in the US, ensuring transparency and traceability of their products.
How are Alifax SRL’s devices classified under US regulations?
All of Alifax SRL’s listed devices fall under Class I regulatory classification in the US. This classification applies to low-risk devices that pose minimal potential harm to users, such as many in-vitro diagnostics (IVDs) like controls, calibrators, and culture media. Class I devices typically require general controls (e.g., proper labeling, manufacturing practices) but do not require pre-market approval.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 435930630
Catalogue (30)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Positive Control Kit | POSITIVE CONTROL KIT | FDA UDI | Class I | Active |
| Latex Controls | LATEX CONTROLS | FDA UDI | Class I | Active |
| Alfred 60/Ast | ALFRED 60/AST | FDA UDI | Class I | Active |
| Test1 Thl | TEST1 THL | FDA UDI | Class I | Active |
| Latex Controls | LATEX CONTROLS | FDA UDI | Class I | Active |
| Light Scattering Test Kit | LIGHT SCATTERING TEST KIT | FDA UDI | Class I | Active |
| Roller 20 | ROLLER 20 | FDA UDI | Class I | Active |
| Test1 Xdl | TEST1 XDL | FDA UDI | Class I | Active |
| Latex Eqe (2 Test) | LATEX EQE (2 TEST) | FDA UDI | Class I | Active |
| Uro-Quick Screening Kit | URO-QUICK SCREENING KIT | FDA UDI | Class I | Active |
| Test1 Ydl | TEST1 YDL | FDA UDI | Class I | Active |
| Latex Eqe (2 Test) | LATEX EQE (2 TEST) | FDA UDI | Class I | Active |
| Latex Controls | LATEX CONTROLS | FDA UDI | Class I | Active |
| Raa Bacterial Reagent Pack | RAA BACTERIAL REAGENT PACK | FDA UDI | Class I | Active |
| Latex Calibrators | LATEX CALIBRATORS | FDA UDI | Class I | Active |
| Jo-Plus | JO-PLUS | FDA UDI | Class I | Active |
| Roller 20 | ROLLER 20 | FDA UDI | Class I | Active |
| Test1 Sdl | TEST1 SDL | FDA UDI | Class I | Active |
| Alfred 60 | ALFRED 60 | FDA UDI | Class I | Active |
| Roller 10 Plus Needle | ROLLER 10 PLUS NEEDLE | FDA UDI | Class I | Active |
| Uro-Quick Raa Kit | URO-QUICK RAA KIT | FDA UDI | Class I | Active |
| Latex Eqe (2 Test) | LATEX EQE (2 TEST) | FDA UDI | Class I | Active |
| Hb&L Uroquattro Light | HB&L UROQUATTRO LIGHT | FDA UDI | Class I | Active |
| Latex Controls | LATEX CONTROLS | FDA UDI | Class I | Active |
| Latex Calibrators | LATEX CALIBRATORS | FDA UDI | Class I | Active |
| Hb&L Uroquattro | HB&L UROQUATTRO | FDA UDI | Class I | Active |
| Test1 Bcl | TEST1 BCL | FDA UDI | Class I | Active |
| Test1 2.0 | TEST1 2.0 | FDA UDI | Class I | Active |
| Automation Kit | AUTOMATION KIT | FDA UDI | Class I | Active |
| Test1 Mdl | TEST1 MDL | FDA UDI | Class I | Active |
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