AccessGUDID - DEVICE: Antiserum to Human Prealbumin (B1761540)

GUDID

Device Identifier (DI) Information

Brand Name: Antiserum to Human Prealbumin
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 154002
Company Name: KENT LABORATORIES INC

Primary DI Number: B1761540
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 093642254 *Terms of Use

Device Description: Goat antiserum to Human Prealbumin

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):	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?
57532	Prealbumin (transthyretin) IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of prealbumin (transthyretin) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JZJ	Prealbumin, Antigen, Antiserum, Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K850686	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9cc6b24f-4d92-4903-b91d-9ff7a16e7e4a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 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

[?]

No Customer Contact currently defined

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