AccessGUDID - DEVICE: GammaZyme-F (10888234000709)

GUDID

Device Identifier (DI) Information

Brand Name: GammaZyme-F
Version or Model: 0007056
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0007056
Company Name: IMMUCOR, INC.

Primary DI Number: 10888234000709
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 061446282 *Terms of Use

Device Description: GammaZyme-F is used in two-stage (pretreatment of red blood cells) enzyme test systems for blood group antibody detection. GammaZyme-F is a stabilized solution of ficin, and this product is in a single vial configuration.

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
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?
52714	Ficin immunohaematology reagent IVD	A substance or reactant that is a ficin enzyme solution intended to be used in immunohaematological testing of a clinical specimen to enhance or potentiate red cell agglutination reactions by enzymatically digesting red cell membrane proteins and removing sialic acid residues.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSK	Solution, Stabilized Enzyme

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK880016	0

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 1 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 92160fc0-afef-46df-afbb-edf2747c618d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 15, 2016