FDA.reportPublic FDA data

REAGENT SPOT INDOLE DMACA

Primary DI
05032384127993
Brand
REAGENT SPOT INDOLE DMACA
Company
OXOID LIMITED
Model
MB1448A
Published
2025-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LIBDevice, General Purpose, Microbiology, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIBDevice, General Purpose, Microbiology, DiagnosticMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05032384127993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05032384127993050323841279935032384127993

GMDN Terms#

Term, Definition table
TermDefinition
Multiple bacteria species culture isolate identification control IVD, kitA collection of reagents and other associated materials intended to be used to verify the performance of one or multiple biochemical tests used for the differentiation and/or identification of multiple bacteria species that have been isolated by culture from a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
365355452
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
05032384029600ANAEROJAR BASEAG0026A2022-12-12
05032384029044STAPHYTECT PLUSDR0850M2026-01-28
05032384029051STAPHYTECT PLUSDR0850B2026-01-28
05032384550784Thermo Scientific Oxoid Gepotidacin Disc (10 ug) GEP10CT1975B2026-01-21
05032384533121Oxoid Aztreonam/Avibactam Disc (30/20ug) AZA50CT1971B2025-12-12
05032384003914SELENITE CYST.BROTH BASECM0699B2025-07-23
05032384126453PEPTONE WATER (ANDRADE)CM0061B2025-06-27
05032384502974IMAGEN Parainfluenza Virus Types 1, 2 and 3K610411-22024-12-30
05032384502981IMAGEN Influenza Virus A and BK610511-22024-12-30
05032384012039AMPICILLIN SELECTIVE SUPP. 1 X 10 VIALSSR0136E2022-12-02
05032384082919ORSAB SELECTIVE SUPPLEMENTSR0195E2024-10-29
05032384083237OXACILLIN RES. SCREENING AGAR BASECM1008B2024-10-29
05032384516018Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test DiscsCT1954B2024-10-28
05032384537723Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 Antimicrobial Susceptibility Test DiCT1960B2024-10-28
05032384128006Microbact Staph 12SMB1561A2024-10-28
05032384128013Microbact Staph Fast Blue ReagentMB1588A2024-10-28
05032384580231Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test DiscsCT1954B2024-10-28
05032384579945Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 Antimicrobial Susceptibility Test DiCT1960B2024-10-28
05700573075706NAK610611-22016-09-24
05032384001774TRYPTONE SOYA BROTHCM0131B2022-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30197344074369MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
30197344074376MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
30197344074383MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
30197344074390MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
20197344074362MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
20197344074379MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
20197344074386MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
20197344074393MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
06973267011369RIGID INOCULATION LOOP,1UL,TUBE PACK,TYPENEX,LP0102TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267011376FLEXIBLE INOCULATION LOOP,1UL,TUBE PACK,TYPENEX,LP0103TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267012366RIGID INOCULATION LOOP,10UL,TUBE PACK,TYPENEX,LP0202TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267012373FLEXIBLE INOCULATION LOOP,10UL,TUBE PACK,TYPENEX,LP0203TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267013349RIGID INOCULATION NEEDLE,TUBE PACK,TYPENEX,LP0302TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267011345RIGID INOCULATION LOOP,1UL,TUBE PACK,TYPENEX,LP0102TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267011352FLEXIBLE INOCULATION LOOP,1UL,TUBE PACK,TYPENEX,LP0103TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267012342RIGID INOCULATION LOOP,10UL,TUBE PACK,TYPENEX,LP0202TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267012359FLEXIBLE INOCULATION LOOP,10UL,TUBE PACK,TYPENEX,LP0203TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267013332RIGID INOCULATION NEEDLE,TUBE PACK,TYPENEX,LP0302TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
09555240404992SCU Narrow Cap SamplerITL ASIA PACIFIC SDN. BHD.LIB2025-06-04
19555240404999SCU Narrow Cap SamplerITL ASIA PACIFIC SDN. BHD.LIB2025-06-04
09555240405593SCU Narrow Cap Sampler Syringe KitITL ASIA PACIFIC SDN. BHD.LIB2025-04-21
19555240405590SCU Narrow Cap Sampler Syringe KitITL ASIA PACIFIC SDN. BHD.LIB2025-04-21
06973267011260Inoculating Loop 1ul rigid perforated bag pack Typenex, LP0102PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267011277Inoculating Loop 1ul flexible perforated bag packTypenex LP0103PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267012267Inoculating Loop 10ul rigid perforated bag packTypenex LP0202PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267012274Inoculating Loop 10ul flexible Typenex LP0203PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267013240Inoculating Needle Rigid perforated bag packTypenex LP0302PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267011246Inoculating Loop 1ul rigid perforated bag pack Typenex, LP0102PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267011253Inoculating Loop 1ul flexible perforated bag packTypenex LP0103PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267012243Inoculating Loop 10ul rigid perforated bag packTypenex LP0202PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13