AccessGUDID - DEVICE: Parasite Suspensions (10845357035063)

GUDID

Device Identifier (DI) Information

Brand Name: Parasite Suspensions
Version or Model: FP01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FP01
Company Name: MICROBIOLOGICS INC.

Primary DI Number: 10845357035063
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 060467826 *Terms of Use

Device Description: Parasite Suspensions Giardia lamblia

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?
47360	Multiple faecal parasite antigen IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple faecal parasite antigens (e.g., Giardia, Entamoeba and Cryptosporidium species) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LIB	DEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 08c0d9cf-c74c-4de1-bd4e-8dc3bb722509
Public Version Date: May 08, 2020
Public Version Number: 1
DI Record Publish Date: April 30, 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(320)253-7400
Email: techsupport@microbiologics.com

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