CD-Chex Plus 213331
GUDID 20844509000093
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials of CD4L level.
STRECK, INC.
Multiple CD cell marker IVD, control| Primary Device ID | 20844509000093 |
| NIH Device Record Key | b4e0f0ec-05f0-496f-9152-c2a08e8724d4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CD-Chex Plus |
| Version Model Number | 213331 |
| Catalog Number | 213331 |
| 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 | |
| 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 | |
| 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 | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 Milliliter |
| Total Volume | 2.5 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 |
| 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 | 20844509000093 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K960894
FDA Product Code
| GGL | Control, White-Cell |
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 | 2016-09-16 |
On-Brand Devices [CD-Chex Plus]
| 00844509000174 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vi |
| 00844509000167 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vi |
| 00844509000150 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vi |
| 00844509000129 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vi |
| 00844509000112 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vi |
| 00844509000105 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vi |
| 40844509000141 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vi |
| 40844509000134 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vi |
| 40844509000080 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 8 vi |
| 30844509000144 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vi |
| 30844509000137 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vi |
| 30844509000090 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 v |
| 30844509000083 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vi |
| 20844509000147 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vi |
| 20844509000130 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vi |
| 20844509000093 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vi |
| 20844509000086 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vi |
| 10844509000096 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 v |
| 10844509000089 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vi |
Trademark Results [CD-Chex Plus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CD-CHEX PLUS 86112962 4779896 Live/Registered |
Streck, Inc. 2013-11-07 |
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