FDA.reportPublic FDA data

STEROID-SKREEN

Primary DI
00810042681941
Brand
STEROID-SKREEN
Company
BIOCHEMICAL DIAGNOSTICS INC
Model
35061843
Catalog number
35061843
Device description
POTASSIUM HYDROXIDE, 7N, 2.0L
Published
2020-04-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CCYZimmerman (Spectrophotometric), 17-Ketosteroids
CCZZimmerman/Norymberski, 17-Ketogenic Steroids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCYZimmerman (Spectrophotometric), 17-KetosteroidsClinical Chemistry1
CCZZimmerman/Norymberski, 17-Ketogenic SteroidsClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810042681941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810042681941008100426819418100426819410810042681941

GMDN Terms#

Term, Definition table
TermDefinition
17-Ketosteroid (17KS) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of 17-ketosteroids (17KS) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
028007698
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810042684416DETECTABUSE18008790180087902025-06-13
00810042684423DETECTABUSE18008791180087912025-06-13
00810042684430DETECTABUSE18008792180087922025-06-13
00810042684447DETECTABUSE18008793180087932025-06-13
00810042684119DETECTABUSE18008255180082552024-06-12
00810042684126DETECTABUSE18008256180082562024-06-12
00810042684133DETECTABUSE18008288180082882024-06-12
00810042684140DETECTABUSE18008289180082892024-06-12
00810042684355DETECTABUSE7020407020402025-03-19
00810042684362CliawaivedMultitox-PC-25GMultitox-PC-25G2025-03-17
00810042683822DETECTABUSE26797267972025-02-20
00810042684331DETECTABUSE18008622180086222024-12-09
00810042684348DETECTABUSE18008623180086232024-12-09
00810042684324CliawaivedMultitox-PC-25FMultitox-PC-25F2024-11-21
00810042684263DETECTABUSE19481310194813102024-10-31
00810042684270DETECTABUSE19481320194813202024-10-31
00810042684287DETECTABUSE19481340194813402024-10-31
00810042684294DETECTABUSE19481350194813502024-10-31
00810042684300DETECTABUSE19481360194813602024-10-31
00810042684317DETECTABUSE19481370194813702024-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810042681705STEROID-SKREENBIOCHEMICAL DIAGNOSTICS INCCCY2020-05-30
00810042681873STEROID-SKREENBIOCHEMICAL DIAGNOSTICS INCCCY2020-05-30
00810042681859STEROID-SKREENBIOCHEMICAL DIAGNOSTICS INCCCZ2020-05-08
00810042681897STEROID-SKREENBIOCHEMICAL DIAGNOSTICS INCCCY2020-05-08
00810042681842STEROID-SKREENBIOCHEMICAL DIAGNOSTICS INCCCY2020-04-30
00810042681903STEROID-SKREENBIOCHEMICAL DIAGNOSTICS INCCCY2020-04-30
00810042681910STEROID-SKREENBIOCHEMICAL DIAGNOSTICS INCCCZ2020-04-30
00810042681910STEROID-SKREENBIOCHEMICAL DIAGNOSTICS INCCCY2020-04-30
00810042681927STEROID-SKREENBIOCHEMICAL DIAGNOSTICS INCCCZ2020-04-30
00810042681934STEROID-SKREENBIOCHEMICAL DIAGNOSTICS INCCCZ2020-04-30
00810042681972STEROID-SKREENBIOCHEMICAL DIAGNOSTICS INCCCY2020-04-30
00810042681989STEROID-SKREENBIOCHEMICAL DIAGNOSTICS INCCCY2020-04-30
00810042682016STEROID-SKREENBIOCHEMICAL DIAGNOSTICS INCCCY2020-04-30
00810042682023STEROID-SKREENBIOCHEMICAL DIAGNOSTICS INCCCY2020-04-30
00810042682030STEROID-SKREENBIOCHEMICAL DIAGNOSTICS INCCCY2020-04-30
00810042682047STEROID-SKREENBIOCHEMICAL DIAGNOSTICS INCCCY2020-04-30
00810042682092STEROID-SKREENBIOCHEMICAL DIAGNOSTICS INCCCY2020-04-30
00810042682115STEROID-SKREENBIOCHEMICAL DIAGNOSTICS INCCCY2020-04-30
00810042682122STEROID-SKREENBIOCHEMICAL DIAGNOSTICS INCCCY2020-04-30
00810042682139STEROID-SKREENBIOCHEMICAL DIAGNOSTICS INCCCY2020-04-30
00810042682368STEROID-SKREENBIOCHEMICAL DIAGNOSTICS INCCCY2020-04-30
00810042682375STEROID-SKREENBIOCHEMICAL DIAGNOSTICS INCCCY2020-04-30