Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry FDA UDI
- Device Name
- Alinity c Lactate Dehydrogenase Reagent Kit 1960 Tests FDA UDI
- Model / Reference
- 07P7430 FDA UDI
- Description
- Alinity c Lactate Dehydrogenase Reagent Kit 1960 Tests FDA UDI
Identifiers
- Catalog Number
- 07P7430 FDA UDI
- Primary DI / UDI-DI
- 00380740130251 FDA UDI
- FDA Product Code
- CFJ FDA UDI
- GMDN Term
- Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1440 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
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: Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry
Alinity by Abbott — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry.
- Lactate dehydrogenase liquid acc to IFCC — Roche Diagnostics Corp. · Class II
- Lactate Dehydrogenase acc to IFCC ver2 — Roche Diagnostics Corp. · Class II
- LD opt. (LDH P-L) — Randox Laboratories, Ltd. · Class II
- LD opt. (LDH L-P) — Randox Laboratories, Ltd. · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- LDH-L SL — VITALSCIENTIFIC
- Lactate dehydrogenase liquid acc to IFCC — Roche Diagnostics Corp. · Class II
- ADVIA® Chemistry LDPL Reagents — Siemens Healthcare Diagnostics · Class II
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abbott
Sources (1)
- FDA UDI 80bd31d2-eb9e-4519-8247-8dcf971fd6db 36 fields · synced May 29, 2026