AccessGUDID - DEVICE: Lyphochek (00847661002086)

GUDID

Device Identifier (DI) Information

Brand Name: Lyphochek
Version or Model: 500X
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 500X
Company Name: BIO-RAD LABORATORIES, INC.

Primary DI Number: 00847661002086
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 051624070 *Terms of Use

Device Description: Lyphochek Anemia Control MiniPak (A human based assayed anemia control.)

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
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?
60998	Multiple anaemia-related analyte IVD, control	A material which is used to verify the performance of one or multiple assays intended to be used for the qualitative and/or quantitative detection of anaemia-related analytes in a clinical specimen, and which together create an anaemia profile. Analytes detected may include (but are not limited to) iron, ferritin, folate (vitamin B9), prealbumin, transferrin and vitamin B12.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJY	Multi-analyte controls, all kinds (assayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K992741	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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bd69188a-b4ba-4b78-971c-d0c34fbd9d5f
Public Version Date: January 31, 2023
Public Version Number: 2
DI Record Publish Date: September 14, 2020

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(800)854-6737
Email: qsd.techservice@bio-rad.com

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

FDA TOOLS & RESOURCES