Primary Device ID | 04987153301030 |
NIH Device Record Key | efefcf64-1e8b-41c1-8433-2838e1048c07 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Lucica® Glycated Albumin-L ALB R-1 |
Version Model Number | L232GA |
Catalog Number | L232GA |
Company DUNS | 700853096 |
Company Name | ASAHI KASEI PHARMA CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +18005315535 |
techsupport@ekfdiagnostics.com |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04987153301030 [Primary] |
LCP | ASSAY, GLYCOSYLATED HEMOGLOBIN |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-03-11 |
Device Publish Date | 2019-02-22 |
04987153301016 - Lucica® Glycated Albumin-L GA R-1 | 2019-10-29 GA R-1 Pretreatment solution 40 mL x 2 |
04987153301023 - Lucica® Glycated Albumin-L GA R-2 | 2019-03-11 GA R-2 Enzymatic solution 10mL x 2 |
04987153301030 - Lucica® Glycated Albumin-L ALB R-1 | 2019-03-11ALB R-1 Pretreatment solution 40 mL x 2 |
04987153301030 - Lucica® Glycated Albumin-L ALB R-1 | 2019-03-11 ALB R-1 Pretreatment solution 40 mL x 2 |
04987153301047 - Lucica® Glycated Albumin-L ALB R-2 | 2019-03-11 ALB R-2 Coloring solution 20mL x 2 |
04987153301054 - Calibrator for Lucica® Glycated Albumin-L | 2019-03-11 Calibrator L (1 mL × 1), Calibrator H (1 mL × 1) |
04987153301061 - Control for Lucica® Glycated Albumin-L | 2019-03-11 Control L (3 mL × 1), Control H (3 mL × 1) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LUCICA 78794840 3705352 Live/Registered |
Asahi Kasei Pharma Corporation 2006-01-19 |