DIASTIX® 2806
GUDID 40301932806509
Reagent strips for urinalysis - glucose. 50 test strips.
ASCENSIA DIABETES CARE US INC.
Urine glucose IVD, kit, colorimetric dipstick, rapid| Primary Device ID | 40301932806509 |
| NIH Device Record Key | f2624764-af8b-474a-8322-6870d6cfed84 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DIASTIX® |
| Version Model Number | 2806 |
| Catalog Number | 2806 |
| Company DUNS | 080028910 |
| Company Name | ASCENSIA DIABETES CARE US INC. |
| Device Count | 50 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 months after first opening. Use only if tamper evident seals on carton are intact |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00301932806013 [Unit of Use] |
| GS1 | 00301932806501 [Package] Contains: 10301932806508 Package: carton [1 Units] In Commercial Distribution |
| NDC/NHRIC | 0193-2802-50 [Secondary] |
| GS1 | 10301932806508 [Primary] |
| GS1 | 40301932806509 [Package] Contains: 00301932806501 Package: shipper/case [24 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K831600
FDA Product Code
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) |
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 | 2019-06-07 |
| Device Publish Date | 2016-09-16 |
On-Brand Devices [DIASTIX®]
| 40301932806509 | Reagent strips for urinalysis - glucose. 50 test strips. |
| 40301932803218 | Reagent strips for urinalysis - glucose. 100 test strips. |
Trademark Results [DIASTIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIASTIX 72047810 0672032 Live/Registered |
AMES COMPANY, INC. 1958-03-17 |
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