Para 4 215428
GUDID 00844509000815
A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contains 4 vials each of normal & high levels.
STRECK, INC.
Full blood count IVD, control| Primary Device ID | 00844509000815 |
| NIH Device Record Key | ff367af2-2c1b-4cd5-83b3-ddb84b4f43c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Para 4 |
| Version Model Number | 215428 |
| Catalog Number | 215428 |
| Company DUNS | 072915986 |
| Company Name | STRECK, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 1-800-228-6090 |
| custserv@streck.com |
Device Dimensions
| Total Volume | 1.5 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00844509000815 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K842017
FDA Product Code
| JPK | Mixture, Hematology Quality Control |
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 | 2016-09-14 |
On-Brand Devices [Para 4]
| 00844509000815 | A multi-parameter hematology control for small laboratories and point-of-care applications that |
| 00844509000808 | A multi-parameter hematology control for small laboratories and point-of-care applications that |
| 00844509000792 | A multi-parameter hematology control for small laboratories and point-of-care applications that |
| 00844509000785 | A multi-parameter hematology control for small laboratories and point-of-care applications that |
| 00844509000778 | A multi-parameter hematology control for small laboratories and point-of-care applications that |
| 00844509000761 | A multi-parameter hematology control for small laboratories and point-of-care applications that |
| 00844509000754 | A multi-parameter hematology control for small laboratories and point-of-care applications that |
| 00844509000747 | A multi-parameter hematology control for small laboratories and point-of-care applications that |
| 00844509000730 | A multi-parameter hematology control for small laboratories and point-of-care applications that |
| 00844509000723 | A multi-parameter hematology control for small laboratories and point-of-care applications that |
| 00844509000716 | A multi-parameter hematology control for small laboratories and point-of-care applications that |
| 40844509000707 | A multi-parameter hematology control for small laboratories and point-of-care applications that |
| 40844509000691 | A multi-parameter hematology control for small laboratories and point-of-care applications that |
| 40844509000684 | A multi-parameter hematology control for small laboratories and point-of-care applications that |
| 30844509000700 | A multi-parameter hematology control for small laboratories and point-of-care applications that |
| 30844509000694 | A multi-parameter hematology control for small laboratories and point-of-care applications that |
| 30844509000687 | A multi-parameter hematology control for small laboratories and point-of-care applications that |
Trademark Results [Para 4]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PARA 4 97747931 not registered Live/Pending |
Microbe Formulas, LLC 2023-01-10 |
 PARA 4 87080205 5119475 Live/Registered |
Streck, Inc. 2016-06-22 |
 PARA 4 73494570 1363924 Dead/Cancelled |
STRECK LABORATORIES, INC. 1984-08-13 |
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