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ENZYMES LINEARITY VERIFIER (For Roche Systems) (ENZYMES LIN VER ROCHE)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- ENZYMES LINEARITY VERIFIER (For Roche Systems) (ENZYMES LIN VER ROCHE) FDA UDI
- Generic Name
- Multiple clinical chemistry enzyme IVD, control FDA UDI
- Device Name
- Enzymes Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for ALT, AST, Alkaline Phosphatase (ALP), Total Amylase, Pancreatic Amylase, CK, CKMB, Gamma GT, LDH and Lipase assays. FDA UDI
- Model / Reference
- LV10366 FDA UDI
- Description
- Enzymes Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for ALT, AST, Alkaline Phosphatase (ALP), Total Amylase, Pancreatic Amylase, CK, CKMB, Gamma GT, LDH and Lipase assays. FDA UDI
Identifiers
- Catalog Number
- LV10366 FDA UDI
- Primary DI / UDI-DI
- 05055273216486 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Multiple clinical chemistry enzyme 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 clinical chemistry enzyme IVD, control
ENZYMES LINEARITY VERIFIER (For Roche Systems) (ENZYMES 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 513e3c0b-fd66-43e6-b785-42f068cd4919 36 fields · synced Jun 6, 2026