QUANTA Flash® Calprotectin Calibrators
GUDID 08426950907220
1. QUANTA Flash Calprotectin Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain recombinant calprotectin with stabilizers and preservatives. 2. QUANTA Flash Calprotectin Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain recombinant calprotectin with stabilizers and preservatives. 3. QUANTA Flash Calprotectin Calibrator 3: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain recombinant calprotectin with stabilizers and preservatives.
INOVA DIAGNOSTICS, INC.
Calprotectin IVD, calibrator| Primary Device ID | 08426950907220 |
| NIH Device Record Key | cd83b1a8-22c6-4498-aaa9-4e8365eeb225 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QUANTA Flash® Calprotectin Calibrators |
| Version Model Number | 701351 |
| Company DUNS | 188354831 |
| Company Name | INOVA DIAGNOSTICS, 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
| Phone | 1-800-545-9495 |
| support@inovadx.com | |
| Phone | 1-800-545-9495 |
| support@inovadx.com | |
| Phone | 1-800-545-9495 |
| support@inovadx.com | |
| Phone | 1-800-545-9495 |
| support@inovadx.com | |
| Phone | 1-800-545-9495 |
| support@inovadx.com | |
| Phone | 1-800-545-9495 |
| support@inovadx.com |
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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08426950907220 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170993
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 | 2022-06-10 |
| Device Publish Date | 2018-02-28 |
Devices Manufactured by INOVA DIAGNOSTICS, INC.
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Trademark Results [QUANTA Flash]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUANTA FLASH 77963733 4071260 Live/Registered |
Inova Diagnostics, Inc. 2010-03-19 |
 QUANTA FLASH 77729358 4067677 Live/Registered |
Inova Diagnostics, Inc. 2009-05-05 |
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