| Primary Device ID | 00813382010150 |
| NIH Device Record Key | b73d6c6f-86ce-4393-99e1-561f4d111a98 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CLA® Allergen-Specific IgE Assay - Southwestern Inhalant Panel |
| Version Model Number | 84509 |
| Catalog Number | 84509 |
| Company DUNS | 102113867 |
| Company Name | HITACHI CHEMICAL DIAGNOSTICS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com | |
| Phone | +1(650)961-5501 |
| info@hcdiagnostics.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813382010150 [Primary] |
| DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-19 |
| 00813382010204 - OPTIGEN® AP 3600™ Automated Instrument | 2019-05-30 Automated In Vitro Allergy Diagnostic System |
| 00813382010426 - OPTIGEN® Allergen-Specific IgE Assay - US Inhalant 36(100 ND) | 2019-05-30 KIT, OPTIGEN US Inhalant 36 (100 ND) |
| 00813382010433 - OPTIGEN® Allergen-Specific IgE Assay - US Food 25 (100 ND) | 2019-05-30 KIT, OPTIGEN US Food 25 (100 ND) |
| 00813382010440 - OPTIGEN® Allergen-Specific IgE Assay - US Food 25 (100 ND) | 2019-05-30 KIT, OPTIGEN US Food 25 |
| 00813382010006 - OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel | 2018-07-06 KIT, OPTIGEN Universal Panel 20 |
| 00813382010075 - OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel | 2018-07-06 KIT, OPTIGEN Universal Panel 20 |
| 00813382010082 - OPTIGEN® Positive Control Reagent | 2018-07-06 OPTIGEN Positive Control |
| 00813382010099 - OPTIGEN® Negative Control Reagent | 2018-07-06 OPTIGEN Negative Control |