| Primary Device ID | 05055273200072 |
| NIH Device Record Key | 331330c4-bafe-48ca-8123-99117f4d311a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ALDOLASE (ALS) |
| Version Model Number | AD189 |
| Company DUNS | 227530649 |
| Company Name | RANDOX LABORATORIES LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055273200072 [Primary] |
| CJC | Fructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-07-06 |
| Device Publish Date | 2019-05-31 |
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