ARCHITECT 01L7601
GUDID 00380740001339
ARCHITECT Sirolimus Calibrators
ABBOTT LABORATORIES
Rapamycin (sirolimus) therapeutic drug monitoring IVD, calibrator| Primary Device ID | 00380740001339 |
| NIH Device Record Key | c1a58cec-80bc-4b27-85d2-54cce1cc8cae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARCHITECT |
| Version Model Number | 1L76-01 |
| Catalog Number | 01L7601 |
| Company DUNS | 079226220 |
| Company Name | ABBOTT LABORATORIES |
| 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 | false |
| 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 | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 0 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00380740001339 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K070822
FDA Product Code
| JIT | CALIBRATOR, SECONDARY |
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 | 2016-06-06 |
On-Brand Devices [ARCHITECT]
| 00380740169978 | Architect c8000 CRP1 eAssay CD-ROM |
| 00380740169848 | Architect cSystem e-Assay CD-ROM SI-Units/Alternate Units |
| 00380740169831 | ARCHITECT cSystem eAssay CD-ROM Conventional Units/Alternate Units |
| 00380740161323 | ARCHITECT c Systems SI Units / Alternate Units MULTIGENT Assay Disk Version 7.00 |
| 00380740161316 | ARCHITECT c Systems Conventional Units / Alternate Units MULTIGENT Assay Disk Version 7.00 |
| 00380740159429 | ARCHITECT i1000SR System e-Assay CD-ROM |
| 00380740159412 | ARCHITECT i System e-Assay CD-ROM |
| 00380740158507 | CRP Vario |
| 00380740158491 | CRP Vario |
| 00380740157067 | ARCHITECT i1000sr System e-Assay CD ROM |
| 00380740157050 | ARCHITECT i System e-Assay CD-ROM |
| 00380740156909 | ARCHITECT cSystem Theophylline SI Units e-Assay CD-ROM v1.0 |
| 00380740156893 | ARCHITECT cSystem Theophylline Conventional Units e-Assay CD-ROM v1.0 |
| 00380740156886 | ARCHITECT cSystem Phenytoin SI Units e-Assay CD-ROM v1.0 |
| 00380740156879 | ARCHITECT cSystem Phenytoin Conventional Units e-Assay CD-ROM v1.0 |
| 00380740153441 | ARCHITECT i1000SR e-Assay CD-ROM |
| 00380740153434 | ARCHITECT i System e-Assay CD-ROM |
| 00380740152147 | ARCHITECT cSystem SI Units e-Assay CD ROM V15.0 |
| 00380740152130 | ARCHITECT cSystem Conv Units e-Assay CD ROM V15.0 |
| 00380740150150 | ARCHITECT i1000SR System e-Assay CD-ROM |
| 00380740150143 | ARCHITECT i System e-Assay CD-ROM |
| 00380740146689 | ARCHITECT UIBC-L SI Units e-Assay CD ROM |
| 00380740146672 | ARCHITECT UIBC-L Conv Units e-Assay CD ROM |
| 00380740145194 | ARCHITECT TBili Conv Units e-Assay CD-ROM |
| 00380740145156 | ARCHITECT TBili SI Units e- Assay CD-ROM |
| 00380740139537 | ARCHITECT i1000SR System e-Assay CDROM |
| 00380740139520 | ARCHITECT i System e-Assay CD-ROM |
| 00380740138738 | ARCHITECT ROMA |
| 00380740138615 | ARCHITECT i1000SR System e-Assay CD-ROM |
| 00380740138608 | ARCHITECT i System e-Assay CD-ROM |
| 00380740137045 | UIBC |
| 00380740121075 | Lactic Acid |
| 00380740117061 | ARCHITECT c16000 REFURBISHED PROCESSING MODULE |
| 00380740116095 | ARCHITECT c4000 PROCESSING MODULE INTEGRATED |
| 00380740116057 | ARCHITECT c4000 PROCESSING MODULE |
| 00380740116019 | ARCHITECT i1000SR INTEGRATED MODULE |
| 00380740115289 | ABBOTT ARCHITECT Reaction Vessels |
| 00380740112196 | Detergent B |
| 00380740105464 | ARCHITECT CA19-9XR Reagent Kit |
| 00380740103163 | ARCHITECT c8000 REFURBISHED PROCESSING MODULE |
| 00380740103156 | ARCHITECT i1000SR REFURBISHED PROCESSING MODULE |
| 00380740102746 | Hemoglobin A1c |
| 00380740102739 | Hemoglobin A1c Controls |
| 00380740102722 | Hemoglobin A1c Calibrators |
| 00380740102715 | Theophylline |
| 00380740102708 | Phenytoin |
| 00380740102692 | Phenobarbital |
| 00380740102685 | Carbamazepine |
| 00380740102678 | Lipid Multiconstituent Calibrator |
| 00380740101220 | TDM Multiconstituent Calibrator |
Trademark Results [ARCHITECT]
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.