FDA.reportPublic FDA data

DHEA RIA

Primary DI
15099590211622
Brand
DHEA RIA
Company
IMMUNOTECH s.r.o.
Model
DSL8900
Catalog number
DSL8900
Device description
DHEA RIA
Published
2023-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JLKSodium Hydroxide And Phenol Red (Titrimetric), Gastric Acidity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JLKSodium Hydroxide And Phenol Red (Titrimetric), Gastric AcidityClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K921534000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K921534000DSL DHEA (DSL 8900)Diagnostic Systems Laboratories, Inc.1992-05-26JKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590211622PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959021162215099590211622

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
360561849
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590211509DHEA-S-7 RIADSL2700DSL27002023-07-06
15099590211523Ultra-sensitive Estradiol RIADSL4800DSL48002023-07-06
15099590211530ACTIVE Free Testosterone RIADSL4900DSL49002023-07-06
15099590211547Estrone-sulfate RIADSL5400DSL54002023-07-06
15099590211615Estrone RIADSL8700DSL87002023-07-06
15099590211592ACTIVE Aldosterone RIADSL8600DSL86002016-09-09