Testes (Primate) 6748L

GUDID 00845533002912

Antibodies against different structures of the testicle are reported in male sterility with azoospermia. Anti-Leydig cell antibodies are observed in steroid defects. Antibodies staining the interstitial cells of the testis have been detected in patients with Addison's disease.

ZEUS SCIENTIFIC, INC.

Testicle antibody IVD, kit, fluorescent immunoassay
Primary Device ID00845533002912
NIH Device Record Keyab5fe52a-820b-47f0-8800-513ec81ebfc1
Commercial Distribution StatusIn Commercial Distribution
Brand NameTestes (Primate)
Version Model Number6748L
Catalog Number6748L
Company DUNS080953946
Company NameZEUS SCIENTIFIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100845533002912 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-26
Device Publish Date2026-02-18

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00845533002912 - Testes (Primate)2026-02-26Antibodies against different structures of the testicle are reported in male sterility with azoospermia. Anti-Leydig cell antibodies are observed in steroid defects. Antibodies staining the interstitial cells of the testis have been detected in patients with Addison's disease.
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