AccessGUDID - DEVICE: MONOFLUO (00847865001519)

GUDID

Device Identifier (DI) Information

Brand Name: MONOFLUO
Version or Model: 32515
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 32515
Company Name: Bio-RAD Laboratories, Inc.

Primary DI Number: 00847865001519
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 844766394 *Terms of Use

Device Description: MONOFLUO Pneumocystis jirovecii (P. carinii) IFA Test

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:	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?
52096	Pneumocystis jirovecii antigen IVD, kit, direct fluorescent test (DFT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from the fungus Pneumocystis jirovecii (formerly known as P. carinii) in a clinical specimen, using a direct fluorescent test (DFT).	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LYF	PNEUMOCYSTIS CARINII

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K890768	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
Device Size Text, specify: 24 Tests

Device Record Status

Public Device Record Key: 8e59ef7c-0f02-43b5-81ab-3d1cd584975c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 12, 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: +1(800)224-6723
Email: TechSupport.USSD-Redmond@bio-rad.com

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