FDA.reportPublic FDA data

ID indole TDA

Primary DI
03573026092443
Brand
ID indole TDA
Company
BIOMERIEUX SA
Model
ID indole TDA
Device description
Detection in enterobacteria of indole production and the presence of a tryptophan deaminase (TDA). It allows presumptive differentiation of bacteria possessing these characteristics
Published
2019-07-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JSSKIT, IDENTIFICATION, ENTEROBACTERIACEAE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSSKit, Identification, EnterobacteriaceaeMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026092443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026092443035730260924433573026092443

GMDN Terms#

Term, Definition table
TermDefinition
Tryptophan utilization/spot indole microbial reagent IVDA reactant intended to be used in microbial testing to detect tryptophan metabolites (e.g., indole, indole-pyruvic acid) produced via enzymatic breakdown by a microorganism isolated from a clinical specimen by culture.

Storage And Handling#

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

Regulatory Flags#

DUNS number
276816717
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03573026064532VIDAS® Measles IgG302192019-08-30
03573026064518VIDAS® Varicella-Zoster IgG302172016-08-31
03573026610418VITEK®MSVITEKMS SW v1.0 / FlexPrep v1.02019-04-30
03573026644796VIDAS® Varicella-Zoster IgG30217-012026-01-19
03573026550523ETEST® Tigecycline (TGC)Etest® TIGECYCLINE2016-12-12
03573026584139ID color CatalaseID color Catalase2019-07-19
03573026092009ID color CatalaseID color Catalase2019-07-19
03573026559823THxID™ BRAF1.02017-05-12
03573026121631VIDAS® Quality Control307062019-11-19
B0744000160ASTUTE140 Electronic Quality Control (EQC) Device4000164000162016-08-12
B0745000090NEPHROCHECK Calibration Verification (Cal Vers) Kit5000095000092016-08-12
B0745000110NEPHROCHECK Test Kit 5000115000112016-08-12
B0745000130NEPHROCHECK Liquid Control Kit5000135000132016-08-12
03573026547226ETEST® Ertapenem (ETP)ETEST® Ertapenem (ETP)2016-11-18
03573026547271ETEST® Tobramycin (TM)ETEST® Tobramycin (TM)2016-11-18
03573026547295ETEST® Tigecycline (TGC)ETEST® Tigecycline (TGC)2016-11-18
03573026548674ETEST® Ampicillin/sulbactam (2/1) (AB)ETEST® Ampicillin/sulbactam (2/1) (AB)2016-11-18
03573026549046ETEST® Tetracycline (TC)ETEST® Tetracycline (TC)2016-11-18
03573026549077ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)2016-11-18
03573026547196ETEST® Fosfomycin (FM)ETEST® Fosfomycin (FM)2016-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848838023040REMELREMEL, INC.JSS2023-01-03
00848838058110Remel REMEL, INC.JSS2021-11-12
00848838058196RemelREMEL, INC.JSS2021-11-12
30848838058111Remel REMEL, INC.JSS2021-11-12
30848838058197RemelREMEL, INC.JSS2021-11-12
03848838058117Remel REMEL, INC.JSS2021-11-12
03848838058193RemelREMEL, INC.JSS2021-11-12
03573026588410API® 20 E Reagent QCBIOMERIEUX SAJSS2020-04-10
03573026588489API® 20 EBIOMERIEUX SAJSS2020-04-10
03573026588526RAPID 20 E™BIOMERIEUX SAJSS2020-04-10
03573026588649RAPID ID 32 EBIOMERIEUX SAJSS2020-04-10
03573026047702API® 20 NEBIOMERIEUX SAJSS2020-04-10
03573026048136API® 20 E Reagent QCBIOMERIEUX SAJSS2020-04-10
03573026048013API 20 E™BIOMERIEUX SAJSS2020-04-10
03573026048617RAPID 20 E™BIOMERIEUX SAJSS2020-04-10
03573026066574rapid ID 32 EBIOMERIEUX SAJSS2020-04-10