AccessGUDID - DEVICE: XW QC CHECK (14987562490216)

GUDID

Device Identifier (DI) Information

Brand Name: XW QC CHECK
Version or Model: BP935764
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SYSMEX CORPORATION

Primary DI Number: 14987562490216
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690664461 *Terms of Use

Device Description: XW QC CHECK

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
55866	Full blood count IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count, and calculation of red cell parameters and/or platelet count, as well as other general blood evaluation tests [e.g., C-reactive protein (CRP)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JPK	Mixture, hematology quality control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K143577	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 2 Milliliter

Device Record Status

Public Device Record Key: 05f601fa-c714-4420-9db2-9db2f68e5a2d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 13, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(888)879-7639
Email: crc@sysmex.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES