FDA.reportPublic FDA data

InstaTest™

Primary DI
00894175000619
Brand
InstaTest™
Company
Diagnostic Automation, Inc.
Model
DACD330-50
Catalog number
330-50
Device description
ASO Latex Test Kit:Diagnostic Automation Inc. Latex agglutination slide test for the Qualitative and Semi-quantitative determination of Antistreptolysin-O in non-diluted serum.
Published
2021-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GTQAntistreptolysin - Titer/Streptolysin O Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GTQAntistreptolysin - Titer/Streptolysin O ReagentMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00894175000619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00894175000619008941750006198941750006190894175000619

GMDN Terms#

Term, Definition table
TermDefinition
Beta-haemolytic Group A Streptococcus antigen IVD, kit, agglutinationA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Group A beta-haemolytic Streptococcus bacteria in a clinical specimen, using an agglutination method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8185913030OneStep@rapidtest.com

Regulatory Flags#

DUNS number
878252071
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850054026446AccuDiag™ T3 ELISA KitDACD3144-153144-152026-03-02
00850082766024AccuDiag™ Mycoplasma pneumoniae IgG ELISADACD8042-28042-22026-03-02
00894175000725AccuDiag™ ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) ELISA DACD2506-22506-22026-02-27
00850049545433AccuDiag™ Prolactin (PRL) ELISADACD4226-154226-152026-01-30
00850054026712AccuDiag™ LH ELISADACD4225-154225-152026-01-30
00894175000800AccuDiag™ Progesterone ELISADACD2077-152077-152026-01-30
00850054026569QMedix™DACD5102-25102-22024-04-23
00850049545723AccuDiag™ Insulin ELISADACD1606-151606-152026-01-27
00850049545815AccuDiag™ Human Growth Hormone (HGH) ELISADACD1901-151901-152026-01-27
00850054026255AccuDiag™ C-Peptide ELISA KitDACD1293-151293-152026-01-27
00850054026682AccuDiag™ Estradiol ELISA DACD2046-152046-152026-01-27
00850054026705 AccuDiag™ FSH ELISADACD4224-154224-152026-01-27
00850082766017AccuDiag™ Free Estriol ELISA DACD3171-153171-152026-01-27
00894175000770AccuDiag™ 17-alpha-OH Progesterone ELISADACD1292-151292-152026-01-27
00894175000824AccuDiag™ ANST (Androstenedione) ELISADACD1038-151038-152026-01-27
10850049545492QMedix™DACD104110-1-19104110-1-192025-12-24
10850082766007QMedix™DACD113030-1-19113030-1-192025-12-24
00850049545501Diagnostic Automation, Inc.DAI SF2100SF21002025-12-24
00850054026392Diagnostic Automation, Inc.DAI SF2600SF26002025-12-24
00850049545495QMedix™DACD104110-1-19104110-1-192025-12-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336231432Tina-quant Antistreptolysin-O IIRoche Diagnostics GmbHGTQ2026-05-08
07613336231449Tina-quant Antistreptolysin-O IIRoche Diagnostics GmbHGTQ2026-05-08
10673486014051Teco Diagnostics Anti-Streptolysin O (ASO) Reagent SetTECO DIAGNOSTICSGTQ2026-05-07
10673486002447Teco Diagnostics Anti-Streptolysin O (ASO) Reagent SetTECO DIAGNOSTICSGTQ2024-04-02
00630414610856Atellica CH Anti-Streptolysin-O_3 (ASO_3)Siemens Healthcare Diagnostics Inc.GTQ2024-02-02
00630414305097Atellica CH Anti-Streptolysin-O_3 (ASO_3)Siemens Healthcare Diagnostics Inc.GTQ2024-02-02
06971674867067BIOBASEBiobase Biodustry(Shandong)Co., Ltd.GTQ2023-07-24
06971674867074BIOBASEBiobase Biodustry(Shandong)Co., Ltd.GTQ2023-07-24
06971674867081BIOBASEBiobase Biodustry(Shandong)Co., Ltd.GTQ2023-07-24
06971674867104BIOBASEBiobase Biodustry(Shandong)Co., Ltd.GTQ2023-07-24
06971674867111BIOBASEBiobase Biodustry(Shandong)Co., Ltd.GTQ2023-07-24
06971674867128BIOBASEBiobase Biodustry(Shandong)Co., Ltd.GTQ2023-07-24
06971674867135BIOBASEBiobase Biodustry(Shandong)Co., Ltd.GTQ2023-07-24
06971674867838BIOBASEBiobase Biodustry(Shandong)Co., Ltd.GTQ2023-07-24
04015630920860Tina-quant Antistreptolysin ORoche Diagnostics GmbHGTQ2021-01-18
04015630925711Tina-quant Antistreptolysin ORoche Diagnostics GmbHGTQ2021-01-18
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 ReagentsSiemens Healthcare Diagnostics Inc.GTQ2020-09-24
00630414596167Atellica CH ASO_2Siemens Healthcare Diagnostics Inc.GTQ2020-09-24
00842768006036Dimension Vista®Antistreptolysin O Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHGTQ2020-09-24
00842768006791N Latex ASLSiemens Healthcare Diagnostics Products GmbHGTQ2020-09-24
00842768006807N Latex ASLSiemens Healthcare Diagnostics Products GmbHGTQ2020-09-24
10758750002306VITROSORTHO-CLINICAL DIAGNOSTICS, INC.GTQ2020-04-18
10758750002726VITROSORTHO-CLINICAL DIAGNOSTICS, INC.GTQ2020-04-18
10758750002733VITROSORTHO-CLINICAL DIAGNOSTICS, INC.GTQ2020-04-18
07613336133545Tina-quant Antistreptolysin ORoche Diagnostics GmbHGTQ2020-03-05
00380740156251ARCHITECTABBOTT LABORATORIESGTQ2020-03-03
00380740156305ARCHITECTABBOTT LABORATORIESGTQ2020-03-03
05055273204292Anti-Streptolysin O (ASO)RANDOX LABORATORIES LIMITEDGTQ2019-06-03
05055273204315ANTI-STREPTOLYSIN-O 2 (ASO 2)RANDOX LABORATORIES LIMITEDGTQ2019-06-03
05055273204322ANTI-STREPTOLYSIN-O 2 (ASO 2)RANDOX LABORATORIES LIMITEDGTQ2019-06-03