Identity
- Trade Name
- JAS Diagnostics FDA UDI
- Generic Name
- LDL (low density lipoprotein) antibody (anti-LDL) IVD, calibrator FDA UDI
- Device Name
- LDL, OLYMPUS (4x 40 mL, 2x 45mL) FDA UDI
- Model / Reference
- XL-LDL4-40 FDA UDI
- Description
- LDL, OLYMPUS (4x 40 mL, 2x 45mL) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817274021880 FDA UDI
- FDA Product Code
- JHM FDA UDI
- GMDN Term
- LDL (low density lipoprotein) antibody (anti-LDL) IVD, calibrator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1475 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
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: LDL (low density lipoprotein) antibody (anti-LDL) IVD, calibrator
JAS Diagnostics by Drew Scientific , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as LDL (low density lipoprotein) antibody (anti-LDL) IVD, calibrator.
- AU — Beckman Coulter, Inc. · 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Drew Scientific , Ltd.
Sources (1)
- FDA UDI d11465a4-d878-4736-b50c-f928436a7a22 35 fields · synced May 30, 2026