IMMAGE 465365
GUDID 15099590575137
Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator
Beckman Coulter, Inc.
Lipoprotein A IVD, calibrator| Primary Device ID | 15099590575137 |
| NIH Device Record Key | b24a5b6d-ef09-406c-892a-5706e5b431b9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IMMAGE |
| Version Model Number | 465365 |
| Catalog Number | 465365 |
| Company DUNS | 008254708 |
| Company Name | Beckman Coulter, Inc. |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15099590575137 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K000121
FDA Product Code
| JIS | Calibrator, Primary |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-24 |
On-Brand Devices [IMMAGE]
| 15099590575342 | IMMAGE Immunochemistry Systems DIL 2 Diluent 2 |
| 15099590575335 | IMMAGE Immunochemistry Systems DIL 1 Diluent 1 |
| 15099590575328 | IMMAGE Immunochemistry Systems BUF 1 Buffer 1 |
| 15099590575298 | IMMAGE Immunochemistry Systems BUF 2 Buffer 2 |
| 15099590575137 | Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator |
| 15099590233242 | IMMAGE Immunochemistry Systems DNB Antideoxyribonuclease-B Reagent |
| 15099590232634 | Immunochemistry Systems CAL 2 Calibrator 2 |
| 15099590231910 | IMMAGE Immunochemistry Systems CRP C-Reactive Protein Reagent |
| 15099590231903 | IMMAGE Immunochemistry Systems BUF 4 Buffer 4 |
| 15099590231897 | IMMAGE Immunochemistry Systems PAB Prealbumin Reagent |
| 15099590231712 | IMMAGE Immunochemistry Systems Wash Solution |
| 15099590230494 | IMMAGE Immunochemistry Systems KAP Kappa Light Chain Reagent |
| 15099590230487 | IMMAGE Immunochemistry Systems C3 Complement C3 Reagent |
| 15099590230470 | IMMAGE Immunochemistry Systems IGA Immunoglobulin A Reagent |
| 15099590230463 | IMMAGE Immunochemistry Systems LAM Lambda Light Chain Reagent |
| 15099590230456 | IMMAGE Immunochemistry Systems HPT Haptoglobin Reagent |
| 15099590230449 | IMMAGE Immunochemistry Systems C4 Complement C4 Reagent |
| 15099590227043 | IMMAGE Immunochemistry Systems CSF-CAL Cerebrospinal Fluid Protein Calibrator |
| 15099590227029 | IMMAGE Immunochemistry Systems IGE Total Immunoglobulin E Reagent |
| 15099590227005 | IMMAGE Immunochemistry Systems CRPH High Sensitivity CRP Reagent |
| 15099590226985 | IMMAGE Immunochemistry Systems IGU Urine Immunoglobulin G Reagent |
| 15099590226961 | IMMAGE Immunochemistry Systems BUF 3 Buffer 3 |
| 15099590226947 | IMMAGE Immunochemistry Systems RF Rheumatoid Factor Reagent |
| 15099590225384 | Immunochemistry Systems Level 1 Urine Protein Control |
| 15099590224158 | Immunochemistry Systems Level 2 Urine Protein Control |
| 15099590224080 | IMMAGE Immunochemistry Systems CER Ceruloplasmin Reagent |
| 15099590224073 | IMMAGE Immunochemistry Systems PFB Properdin Factor B Reagent |
| 15099590224066 | IMMAGE Immunochemistry Systems AAG Alpha-1-Acid Glycoprotein Reagent |
| 15099590224059 | IMMAGE Immunochemistry Systems AMG Alpha-2-Macroglobulin Reagent |
| 15099590224042 | IMMAGE Immunochemistry Systems AAT Alpha-1-Antitrypsin Reagent |
| 15099590224035 | IMMAGE Immunochemistry Systems APB Apolipoprotein B Reagent |
| 15099590224028 | IMMAGE Immunochemistry Systems AT3 Antithrombin III Reagent |
| 15099590223885 | IMMAGE Immunochemistry Systems IGG Immunoglobulin G Reagent |
| 15099590223878 | IMMAGE Immunochemistry Systems APA Apolipoprotein A1 Reagent |
| 15099590223373 | IMMAGE Immunochemistry Systems FER Ferritin Reagent |
| 15099590223250 | Immunochemistry Systems CAL 3 Calibrator 3 |
| 15099590223243 | IMMAGE Immunochemistry Systems FER CAL Ferritin Calibrator |
| 15099590222673 | Immunochemistry Systems UCAL Urine Protein Calibrator |
| 15099590221225 | IMMAGE Immunochemistry Systems IGALC Low Concentration ImmunoglobuIin A |
| 15099590221218 | IMMAGE Immunochemistry Systems IGMLC Low Concentration ImmunoglobuIin M |
| 15099590221201 | IMMAGE Immunochemistry Systems ALB Albumin Reagent |
| 15099590221195 | IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent |
| 15099590221188 | IMMAGE Immunochemistry Systems ASO Anti-Streptolysin Reagent |
| 15099590221171 | IMMAGE Immunochemistry Systems LPAX Lipoprotein (a) Reagent |
| 15099590203160 | IMMAGE Immunochemistry Systems CCRP High Sensitivity Cardiac CRP Reagent |
| 15099590200060 | Immunochemistry Systems CAL 1 Calibrator 1 |
| 15099590180171 | IMMAGE Immunochemistry Systems TRF Transferrin Reagent |
| 15099590180164 | IMMAGE Immunochemistry Systems MA Microalbumin Reagent |
| 15099590180157 | IMMAGE Immunochemistry Systems TRU Urine Transferrin Reagent |
| 15099590180140 | IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin Reagent |
Trademark Results [IMMAGE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IMMAGE 74649133 2101862 Live/Registered |
BECKMAN COULTER, INC 1995-03-20 |
 IMMAGE 74631264 not registered Dead/Abandoned |
Howell, Howard O. 1995-02-07 |
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