FDA.reportPublic FDA data

API® 20 E

Primary DI
03573026588489
Brand
API® 20 E
Company
BIOMERIEUX SA
Model
API® 20 E
Device description
API 20 E is a standardized identification system for Enterobacteriaceae and other non-fastidious, Gramnegative rods
Published
2020-04-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
03573026047818PackageGS11In Commercial Distribution
03573026048013PackageGS14In Commercial Distribution
03573026588489PrimaryGS10
03573026588496Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026047818035730260478183573026047818
03573026048013035730260480133573026048013
03573026588489035730265884893573026588489
03573026588496035730265884963573026588496

GMDN Terms#

Term, Definition table
TermDefinition
Multiple gram negative bacteria species culture isolate identification IVD, kitA collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of gram negative bacteria belonging to the Enterobacteriaceae or non-Enterobacteriaceae families, that have been isolated by culture from a clinical specimen.

Storage And Handling#

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

Regulatory Flags#

DUNS number
276816717
Device count
25
Premarket exempt
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
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
03573026092443ID indole TDABIOMERIEUX SAJSS2019-07-19