Alfa Wassermann
GUDID 00857969006396
Level 1 Chemistry Control
ALFA WASSERMANN, INC.
Multiple clinical chemistry analyte IVD, control| Primary Device ID | 00857969006396 |
| NIH Device Record Key | bcbbec4f-dc22-4dcc-881b-a92db0064355 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alfa Wassermann |
| Version Model Number | C1-4 |
| Company DUNS | 781990924 |
| Company Name | ALFA WASSERMANN, 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 | 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 | (973) 852-0158 |
| HKatz@AlfaWassermannUS.com | |
| Phone | (973) 852-0158 |
| HKatz@AlfaWassermannUS.com | |
| Phone | (973) 852-0158 |
| HKatz@AlfaWassermannUS.com | |
| Phone | (973) 852-0158 |
| HKatz@AlfaWassermannUS.com | |
| Phone | (973) 852-0158 |
| HKatz@AlfaWassermannUS.com | |
| Phone | (973) 852-0158 |
| HKatz@AlfaWassermannUS.com | |
| Phone | (973) 852-0158 |
| HKatz@AlfaWassermannUS.com | |
| Phone | (973) 852-0158 |
| HKatz@AlfaWassermannUS.com | |
| Phone | (973) 852-0158 |
| HKatz@AlfaWassermannUS.com | |
| Phone | (973) 852-0158 |
| HKatz@AlfaWassermannUS.com | |
| Phone | (973) 852-0158 |
| HKatz@AlfaWassermannUS.com | |
| Phone | (973) 852-0158 |
| HKatz@AlfaWassermannUS.com | |
| Phone | (973) 852-0158 |
| HKatz@AlfaWassermannUS.com | |
| Phone | (973) 852-0158 |
| HKatz@AlfaWassermannUS.com | |
| Phone | (973) 852-0158 |
| HKatz@AlfaWassermannUS.com | |
| Phone | (973) 852-0158 |
| HKatz@AlfaWassermannUS.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Fahrenheit and 8 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Fahrenheit and 8 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Fahrenheit and 8 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Fahrenheit and 8 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Fahrenheit and 8 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Fahrenheit and 8 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Fahrenheit and 8 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Fahrenheit and 8 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Fahrenheit and 8 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Fahrenheit and 8 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Fahrenheit and 8 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Fahrenheit and 8 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Fahrenheit and 8 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Fahrenheit and 8 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Fahrenheit and 8 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857969006396 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K930104
FDA Product Code
| JJY | Multi-Analyte Controls, All Kinds (Assayed) |
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 | 2017-07-25 |
On-Brand Devices [Alfa Wassermann]
| 00857969006433 | Lipid Controls |
| 00857969006426 | Hemoglobin A1c Controls |
| 00857969006402 | Level 2 Chemistry Control |
| 00857969006396 | Level 1 Chemistry Control |
| 00857969006389 | CAL A |
| 00857969006372 | STARLYTE V Fluid Pack |
| 00857969006327 | REFERENCE ELECTRODE SOLUTION |
| 00857969006310 | CAL B |
| 00857969006204 | Hemoglobin A1c Calibrators |
| 00857969006198 | Urine Standard |
| 00857969006181 | GemCal Reference Serum |
| 00857969006051 | Electrode, Chloride |
| 00857969006044 | Electrode, Potassium |
| 00857969006037 | Electrode, Sodium |
| 00857969006600 | Hemoglobin A1c Calibrators |
Trademark Results [Alfa Wassermann]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALFA WASSERMANN 76618507 3238600 Live/Registered |
ALFASIGMA S.P.A. 2004-10-29 |
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