Adenosine Deaminase Assay Kit

GUDID 00817089020825

DIAZYME LABORATORIES, INC.

Adenosine deaminase (ADA) IVD, kit, spectrophotometry
Primary Device ID00817089020825
NIH Device Record Keyf622db21-91ad-4dcf-a38d-7dfa970d109f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdenosine Deaminase Assay Kit
Version Model NumberDZ117A-K
Company DUNS080507219
Company NameDIAZYME LABORATORIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817089020825 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-03
Device Publish Date2023-10-26

Devices Manufactured by DIAZYME LABORATORIES, INC.

00817089021556 - Diazyme2023-12-07
00817089021617 - Diazyme2023-12-07
00817089021662 - Diazyme2023-12-07
00817089022539 - Diazyme2023-12-07
00817089022584 - Diazyme2023-12-07
00817089022744 - Diazyme2023-12-07
00817089023154 - Diazyme2023-12-07
00817089023161 - Diazyme2023-12-07

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