AccessGUDID - DEVICE: Lumipulse G CA125II Calibrators (04987270230688)

GUDID

Device Identifier (DI) Information

Brand Name: Lumipulse G CA125II Calibrators
Version or Model: 230688
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FUJIREBIO INC.

Primary DI Number: 04987270230688
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 710873907 *Terms of Use

Device Description: No description.

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?
38231	Cancer antigen 125 (CA125) IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of cancer antigen 125 (CA125), a marker commonly associated with ovarian cancer, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIT	Calibrator, Secondary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142895	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
Special Storage Condition, Specify: right side up with care; no vibration
Storage Environment Temperature: between 2 and 10 Degrees Celsius
Handling Environment Temperature: between 2 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size Type = Units per Kit; Units = 2; Unit of Measure = 3.0mLs

Device Record Status

Public Device Record Key: 1d5340be-382e-4442-907d-6817a5cb2aa1
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016

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: 610-240-3800
Email: customersupport@fdi.com

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