Identity
- Trade Name
- Lucica® Glycated Albumin-L ALB R-1 FDA UDI
- Generic Name
- Glycated albumin IVD, reagent FDA UDI
- Device Name
- ALB R-1 Pretreatment solution 40 mL x 2 FDA UDI
- Model / Reference
- L232GA FDA UDI
- Description
- ALB R-1 Pretreatment solution 40 mL x 2 FDA UDI
Identifiers
- Catalog Number
- L232GA FDA UDI
- Primary DI / UDI-DI
- 04987153301030 FDA UDI
- FDA Product Code
- LCP FDA UDI
- GMDN Term
- Glycated albumin IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7470 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
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glycated albumin IVD, reagent
Lucica® Glycated Albumin-L ALB R-1 by Asahi Kasei Pharma Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glycated albumin IVD, reagent.
- Diazyme — Diazyme Laboratories, Inc.
- Diazyme — Diazyme Laboratories, Inc.
- Diazyme — Diazyme Laboratories, Inc.
- Lucica® Glycated Albumin-L ALB R-2 — Asahi Kasei Pharma Corporation · Class II
- Lucica® Glycated Albumin-L GA R-2 — Asahi Kasei Pharma Corporation · Class II
- Lucica® Glycated Albumin-L GA R-1 — Asahi Kasei Pharma Corporation · 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
- Asahi Kasei Pharma Corporation
Sources (1)
- FDA UDI efefcf64-1e8b-41c1-8433-2838e1048c07 36 fields · synced Jun 1, 2026