QIAcuityDx® Universal MasterMix Kit 260101
GUDID 04053228049418
The QIAcuityDx® Universal MasterMix Kit is a ready-to-use general purpose dPCR MasterMix reagent set for use with the QIAcuityDx® Four in conjunction with associated assay specific reagents as part of validated diagnostic test procedures. The QIAcuityDx® Universal MasterMix Kit is intended for in vitro diagnostic use. The QIAcuityDx® Universal MasterMix Kit is not an automated device and is intended for laboratory use by trained personnel. It is the user’s responsibility to validate system performance for any procedures used in their laboratory which are not covered by the QIAGEN performance studies.
QIAGEN GmbH
Nucleic acid amplification mastermix kit IVD| Primary Device ID | 04053228049418 |
| NIH Device Record Key | 8f1a3253-a2e2-4d43-bde8-afa960c95d66 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QIAcuityDx® Universal MasterMix Kit |
| Version Model Number | 1 |
| Catalog Number | 260101 |
| Company DUNS | 317103745 |
| Company Name | QIAGEN GmbH |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 8003627737 |
| techservice-na@qiagen.com | |
| Phone | 8003627737 |
| techservice-na@qiagen.com | |
| Phone | 8003627737 |
| techservice-na@qiagen.com | |
| Phone | 8003627737 |
| techservice-na@qiagen.com | |
| Phone | 8003627737 |
| techservice-na@qiagen.com | |
| Phone | 8003627737 |
| techservice-na@qiagen.com | |
| Phone | 8003627737 |
| techservice-na@qiagen.com | |
| Phone | 8003627737 |
| techservice-na@qiagen.com | |
| Phone | 8003627737 |
| techservice-na@qiagen.com | |
| Phone | 8003627737 |
| techservice-na@qiagen.com | |
| Phone | 8003627737 |
| techservice-na@qiagen.com | |
| Phone | 8003627737 |
| techservice-na@qiagen.com | |
| Phone | 8003627737 |
| techservice-na@qiagen.com | |
| Phone | 8003627737 |
| techservice-na@qiagen.com | |
| Phone | 8003627737 |
| techservice-na@qiagen.com | |
| Phone | 8003627737 |
| techservice-na@qiagen.com | |
| Phone | 8003627737 |
| techservice-na@qiagen.com | |
| Phone | 8003627737 |
| techservice-na@qiagen.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -30 Degrees Celsius and -15 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a constant temperature freezer. Protect from light. |
| Storage Environment Temperature | Between -30 Degrees Celsius and -15 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a constant temperature freezer. Protect from light. |
| Storage Environment Temperature | Between -30 Degrees Celsius and -15 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a constant temperature freezer. Protect from light. |
| Storage Environment Temperature | Between -30 Degrees Celsius and -15 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a constant temperature freezer. Protect from light. |
| Storage Environment Temperature | Between -30 Degrees Celsius and -15 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a constant temperature freezer. Protect from light. |
| Storage Environment Temperature | Between -30 Degrees Celsius and -15 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a constant temperature freezer. Protect from light. |
| Storage Environment Temperature | Between -30 Degrees Celsius and -15 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a constant temperature freezer. Protect from light. |
| Storage Environment Temperature | Between -30 Degrees Celsius and -15 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a constant temperature freezer. Protect from light. |
| Storage Environment Temperature | Between -30 Degrees Celsius and -15 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a constant temperature freezer. Protect from light. |
| Storage Environment Temperature | Between -30 Degrees Celsius and -15 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a constant temperature freezer. Protect from light. |
| Storage Environment Temperature | Between -30 Degrees Celsius and -15 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a constant temperature freezer. Protect from light. |
| Storage Environment Temperature | Between -30 Degrees Celsius and -15 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a constant temperature freezer. Protect from light. |
| Storage Environment Temperature | Between -30 Degrees Celsius and -15 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a constant temperature freezer. Protect from light. |
| Storage Environment Temperature | Between -30 Degrees Celsius and -15 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a constant temperature freezer. Protect from light. |
| Storage Environment Temperature | Between -30 Degrees Celsius and -15 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a constant temperature freezer. Protect from light. |
| Storage Environment Temperature | Between -30 Degrees Celsius and -15 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a constant temperature freezer. Protect from light. |
| Storage Environment Temperature | Between -30 Degrees Celsius and -15 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a constant temperature freezer. Protect from light. |
| Storage Environment Temperature | Between -30 Degrees Celsius and -15 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a constant temperature freezer. Protect from light. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04053228049418 [Primary] |
FDA Product Code
| PPM | General Purpose Reagent |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-08 |
| Device Publish Date | 2024-09-30 |
On-Brand Devices [QIAcuityDx® Universal MasterMix Kit]
| 04053228049432 | The QIAcuityDx® Universal MasterMix Kit is a ready-to-use general purpose dPCR MasterMix reagen |
| 04053228049418 | The QIAcuityDx® Universal MasterMix Kit is a ready-to-use general purpose dPCR MasterMix reagen |
Trademark Results [QIAcuityDx]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QIACUITYDX 79406403 not registered Live/Pending |
QIAGEN GmbH 2024-07-25 |
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