CD-Chex CD34 213383
GUDID 30844509000489
A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 2 vials of level 3.
STRECK, INC.
Multiple CD cell marker IVD, control| Primary Device ID | 30844509000489 |
| NIH Device Record Key | 0904f27a-55cc-49e1-8556-70ad05b6b3f7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CD-Chex CD34 |
| Version Model Number | 213383 |
| Catalog Number | 213383 |
| 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 |
Device Dimensions
| Total Volume | 1 Milliliter |
| Total Volume | 1 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 30844509000489 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K993126
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 CD34]
| 00844509000501 | A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 2 |
| 00844509000495 | A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 1 |
| 30844509000489 | A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 2 |
| 30844509000472 | A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 2 |
| 30844509000465 | A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 2 |
| 20844509000482 | A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 1 |
| 20844509000475 | A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 1 |
| 20844509000468 | A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 1 |
Trademark Results [CD-Chex CD34]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CD-CHEX CD34 86112971 4779897 Live/Registered |
Streck, Inc. 2013-11-07 |
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