Ostase®+ BAP EIA
GUDID 05060169690059
IMMUNODIAGNOSTIC SYSTEMS LIMITED
Bone alkaline phosphatase (BALP) IVD, kit, chemiluminescent immunoassay| Primary Device ID | 05060169690059 |
| NIH Device Record Key | b32a3471-68f5-4cc1-8d32-d93727e7b71f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ostase®+ BAP EIA |
| Version Model Number | AC-20F1 |
| 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 |
Customer Support Contacts
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com | |
| Phone | +4401915190660 |
| info.uk@idsplc.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store upon receipt at 2 to 8 degrees celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060169690059 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K972666
FDA Product Code
| CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes |
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 | 2016-04-01 |
Devices Manufactured by IMMUNODIAGNOSTIC SYSTEMS LIMITED
| 05060169695986 - IDS Beta CrossLaps® (CTX-I) | 2024-01-11 |
| 05060169696013 - IDS Beta CrossLaps® (CTX-I) Calibrator Set | 2024-01-11 |
| 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 |
| 05060169691261 - IDS Androstenedione | 2023-07-05 |
Trademark Results [Ostase]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSTASE 74181264 1907801 Live/Registered |
Hybritech Incorporated 1991-07-01 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.