Multi-Collect 9K12-03
GUDID 20884999046515
multi-Collect Specimen Collection Specimen Collection Kit
ABBOTT MOLECULAR INC.
General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium| Primary Device ID | 20884999046515 |
| NIH Device Record Key | dfe1cfb7-b38a-4f36-bd3e-e55f23a76c88 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Multi-Collect |
| Version Model Number | 9K12-03 |
| Catalog Number | 9K12-03 |
| Company DUNS | 878263359 |
| Company Name | ABBOTT MOLECULAR INC. |
| 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
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884999046511 [Primary] |
| GS1 | 20884999046515 [Package] Contains: 00884999046511 Package: Box [50 Units] In Commercial Distribution |
| GS1 | 30884999046512 [Package] Package: Case [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K140354
FDA Product Code
| MKZ | DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2016-09-01 |
On-Brand Devices [Multi-Collect]
| 20884999046522 | multi-Collect Specimen Collection Kit |
| 20884999046515 | multi-Collect Specimen Collection Specimen Collection Kit |
Trademark Results [Multi-Collect]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MULTI-COLLECT 78932757 3610494 Live/Registered |
Abbott Laboratories 2006-07-19 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.