Para 12® Plus 230592
GUDID 30844509000199
Para 12® Plus is an assayed hematology control for evaluating the accuracy and precision of hematology instruments that provide a white blood cell differential.
STRECK, INC.
Full blood count IVD, control| Primary Device ID | 30844509000199 |
| NIH Device Record Key | 068d981b-1035-445e-9c30-984ad1242a6d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Para 12® Plus |
| Version Model Number | 230592 |
| Catalog Number | 230592 |
| Company DUNS | 072915986 |
| Company Name | STRECK, 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-800-228-6090 |
| custserv@streck.com | |
| Phone | 1-800-228-6090 |
| custserv@streck.com | |
| Phone | 1-800-228-6090 |
| custserv@streck.com | |
| Phone | 1-800-228-6090 |
| custserv@streck.com | |
| Phone | 1-800-228-6090 |
| custserv@streck.com | |
| Phone | 1-800-228-6090 |
| custserv@streck.com | |
| Phone | 1-800-228-6090 |
| custserv@streck.com | |
| Phone | 1-800-228-6090 |
| custserv@streck.com | |
| Phone | 1-800-228-6090 |
| custserv@streck.com | |
| Phone | 1-800-228-6090 |
| custserv@streck.com | |
| Phone | 1-800-228-6090 |
| custserv@streck.com | |
| Phone | 1-800-228-6090 |
| custserv@streck.com | |
| Phone | 1-800-228-6090 |
| custserv@streck.com | |
| Phone | 1-800-228-6090 |
| custserv@streck.com |
Device Dimensions
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 30844509000199 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K901875
FDA Product Code
| JCN | Control, Cell Counter, Normal And Abnormal |
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 | 2020-09-01 |
| Device Publish Date | 2020-08-24 |
Devices Manufactured by STRECK, INC.
| 10844509000089 - CD-Chex Plus | 2023-11-20 A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of Normal level. |
| 10844509000096 - CD-Chex Plus | 2023-11-20 A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of CD4L level. |
| 00844509002437 - MDx-Chex for BC-GN | 2023-08-17 MDx-Chex™ for BC-GN is intended for use as an external positive and negative assayed control to monitor the performance of the |
| 00844509002468 - MDx-Chex for BC-GP | 2023-08-17 MDx-Chex™ for BC-GP is intended for use as an external positive and negative assayed control to monitor the performance of the |
| 00844509002376 - Streck Viral Extraction Kit | 2023-06-21 The Streck® Viral Extraction Kit is intended for use in isolating intact virus particles and associated viral nucleic acids (RN |
| 00844509002338 - MDx-Chex for BCID2 | 2022-02-02 MDx-Chex for BCID2 is intended for use as an external positive and negative assayed control to monitor the performance of the qu |
| 30844509000199 - Para 12® Plus | 2020-09-01Para 12® Plus is an assayed hematology control for evaluating the accuracy and precision of hematology instruments that provide a white blood cell differential. |
| 30844509000199 - Para 12® Plus | 2020-09-01 Para 12® Plus is an assayed hematology control for evaluating the accuracy and precision of hematology instruments that provide |
| 00844509002253 - Cell-Free DNA BCT | 2020-08-18 Cell-Free DNA BCT is a direct-draw venous whole blood collection device intended for the collection, stabilization, and transpor |
Trademark Results [Para 12]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PARA 12 73447491 1317494 Live/Registered |
Streck Laboratories, Inc. 1983-10-11 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.