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ESOTERIC LINEARITY VERIFIERS (For Roche Systems) (ESOTERIC LIN VER ROCHE)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- ESOTERIC LINEARITY VERIFIERS (For Roche Systems) (ESOTERIC LIN VER ROCHE) FDA UDI
- Generic Name
- Multiple-type clinical chemistry analyte profile IVD, control FDA UDI
- Device Name
- Esoteric Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of the Roche Systems for Acetaminophen, Ammonia, Ethanol, Salicylate, Microalbumin and Urinary Protein assays. FDA UDI
- Model / Reference
- LV10336 FDA UDI
- Description
- Esoteric Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of the Roche Systems for Acetaminophen, Ammonia, Ethanol, Salicylate, Microalbumin and Urinary Protein assays. FDA UDI
Identifiers
- Catalog Number
- LV10336 FDA UDI
- Primary DI / UDI-DI
- 05055273216165 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Multiple-type clinical chemistry analyte profile IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple-type clinical chemistry analyte profile IVD, control
ESOTERIC LINEARITY VERIFIERS (For Roche Systems) (ESOTERIC LIN VER ROCHE) by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID
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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
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI a767736f-f5ce-4c86-966c-ccf9e5b96153 36 fields · synced May 31, 2026