| Primary Device ID | 05060169690882 |
| NIH Device Record Key | 01eb4faa-c4b6-4c04-9d79-59475d1c1e88 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IDS-iSYS 17-OH Progesterone Control Set |
| Version Model Number | IS-5130 |
| Company DUNS | 494268600 |
| Company Name | IMMUNODIAGNOSTIC SYSTEMS LIMITED |
| 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 | 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 | +4401915190660 |
| info.uk@idsplc.com |
| Special Storage Condition, Specify | Between 0 and 0 *Leave the controls at room temperature for 10 minutes and gently mix the bottles by hand before use. Care should be taken to avoid the formation of foam. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060169690882 [Primary] |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-06-24 |
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| 05060169696051 - IDS Beta CrossLaps® (CTX-I) Control Set | 2024-01-11 |
| 05060169696457 - IDS ACTH II | 2023-08-31 |
| 05060169696495 - IDS ACTH II Calibrator Set | 2023-08-31 |
| 05060169696532 - IDS ACTH II Control Set | 2023-08-31 |
| 05060169691148 - IDS-iSYS SDSpeed Calc | 2023-07-05 |
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