FDA.reportPublic FDA data

Detectabuse

Primary DI
00810042681606
Brand
Detectabuse
Company
BIOCHEMICAL DIAGNOSTICS INC
Model
19582040
Catalog number
19582040
Device description
CONFIRM 3, -60%, 50mL
Published
2020-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DIFDrug Mixture Control Materials

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIFDrug Mixture Control MaterialsClinical Toxicology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810042681606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810042681606008100426816068100426816060810042681606

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
631-595-9200support@biochemicaldiagnostics.com

Regulatory Flags#

DUNS number
028007698
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810042684416DETECTABUSE18008790180087902025-06-13
00810042684423DETECTABUSE18008791180087912025-06-13
00810042684430DETECTABUSE18008792180087922025-06-13
00810042684447DETECTABUSE18008793180087932025-06-13
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
00810042684249DETECTABUSE18008661180086612024-10-02
00810042684256DETECTABUSE18008662180086622024-10-02
00810042684232iScreen88036880362024-07-22
00810042683976DETECTABUSE18001423180014232024-06-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810042684416DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-06-13
00810042684423DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-06-13
00810042684430DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-06-13
00810042684447DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-06-13
00810042684355DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-03-19
00810042684362CliawaivedBIOCHEMICAL DIAGNOSTICS INCDIF2025-03-17
00810042683822DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-02-20
00810042684331DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-12-09
00810042684348DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-12-09
00810042684324CliawaivedBIOCHEMICAL DIAGNOSTICS INCDIF2024-11-21
00810042684263DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684270DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684287DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684294DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684300DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684317DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
00810042684249DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-02
00810042684256DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-02
00810042684232iScreenBIOCHEMICAL DIAGNOSTICS INCDIF2024-07-22
00810042683976DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042683983DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042683990DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684003DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684010DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684027DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684034DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684041DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684058DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684065DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12
00810042684072DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-06-12