FDA.reportPublic FDA data

Adulter-Skreen

Primary DI
00850004812501
Brand
Adulter-Skreen
Company
BIOCHEMICAL DIAGNOSTICS INC
Model
20300002
Catalog number
20300002
Device description
ADULTER-SKREEN DOA Urine Validity Controls
Published
2020-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHQMulti-Analyte Controls Unassayed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHQMulti-Analyte Controls UnassayedClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850004812501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004812501008500048125018500048125010850004812501

GMDN Terms#

Term, Definition table
TermDefinition
Multiple urine analyte IVD, controlA material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 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
true
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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01220000260634NATtrol™ ZEPTOMETRIX CORPORATIONOHQ2025-12-01
70845357044340QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2025-09-08
70845357044395QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2025-09-08
05056850400038Mimix™ Quantitative Multiplex FFPE reference standardREVVITY DISCOVERY LIMITEDOHQ2025-08-15
80845357044422Helix Elite Molecular StandardsMICROBIOLOGICS INC.OHQ2025-08-14
01220000260627NATtrol™ ZEPTOMETRIX CORPORATIONOHQ2025-08-06
04987270235584Lumipulse Infectious Disease ControlsFUJIREBIO INC.OHQ2025-07-31
01220000260481NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-07-25
08718734962991CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734963004CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734963011CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734963028CueSee® BGEMEurotrol B.V.OHQ2025-07-25
01220000260498NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-07-23
00850051429578Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2025-06-20
00850051429639Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2025-06-20
00850051429684Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2025-06-20
05056850400007Mimix™ OncoSpan FFPE Reference StandardREVVITY DISCOVERY LIMITEDOHQ2025-06-05
05056850400014Mimix™ OncoSpan gDNA Reference StandardREVVITY DISCOVERY LIMITEDOHQ2025-06-05
05056850400021Mimix™ Myeloid Cancer Panel gDNA Reference StandardREVVITY DISCOVERY LIMITEDOHQ2025-06-05
01220000260542NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-03-06
08718734962526CueSee VeriSTAT®Eurotrol B.V.OHQ2024-10-29
08718734962618CueSee VeriSTAT®Eurotrol B.V.OHQ2024-10-29
08718734962625CueSee VeriSTAT®Eurotrol B.V.OHQ2024-10-29
08718734962632CueSee VeriSTAT®Eurotrol B.V.OHQ2024-10-29
10845357044324Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.OHQ2024-09-04
70845357044364QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2024-09-04
03610522384372Exact DiagnosticsEXACT DIAGNOSTICS, LLCOHQ2024-08-27
03610522384389Exact DiagnosticsEXACT DIAGNOSTICS, LLCOHQ2024-08-27