FDA.reportPublic FDA data

ID 32 STAPH

Primary DI
03573026066499
Brand
ID 32 STAPH
Company
BIOMERIEUX SA
Model
ID 32 STAPH
Device description
ID 32 STAPH is a standardized system for the identification of the genera Staphylococcus, Micrococcus and related genera, Rothia and Aerococcus
Published
2020-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JWXKIT, SCREENING, STAPHYLOCOCCUS AUREUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWXKit, Screening, Staphylococcus AureusMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026066499PackageGS125In Commercial Distribution
03573026588601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026066499035730260664993573026066499
03573026588601035730265886013573026588601

GMDN Terms#

Term, Definition table
TermDefinition
Multiple aerobic gram positive 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 aerobic gram positive bacteria that have been isolated by culture from a clinical specimen. Bacteria which may be identified typically belong to the genera Staphylococcus, Enterococcus, or may represent other gram positive cocci and gram positive bacilli genera.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
276816717
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
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
05032384029044STAPHYTECT PLUSOXOID LIMITEDJWX2026-01-28
05032384029051STAPHYTECT PLUSOXOID LIMITEDJWX2026-01-28
00816057021826ASI Color Staph Latex TestARLINGTON SCIENTIFIC, INC.JWX2023-12-19
00816057021833ASI Color Staph Latex TestARLINGTON SCIENTIFIC, INC.JWX2023-12-19
00816057021840ASI Color Staph Latex TestARLINGTON SCIENTIFIC, INC.JWX2023-12-19
00848838022982Remel REMEL, INC.JWX2021-11-12
00848838023002Remel REMEL, INC.JWX2021-11-12
30848838022983Remel REMEL, INC.JWX2021-11-12
30848838023003Remel REMEL, INC.JWX2021-11-12
03848838022989Remel REMEL, INC.JWX2021-11-12
03848838023009Remel REMEL, INC.JWX2021-11-12
05056080501512Staphaurex Plus (150 test)REMEL EUROPE LIMITEDJWX2021-07-21
05056080501529Staphaurex Plus (450 test)REMEL EUROPE LIMITEDJWX2021-07-21
03573026588601ID 32 STAPHBIOMERIEUX SAJWX2020-04-10
03573026048259API® StaphBIOMERIEUX SAJWX2020-04-10
20885380020176CARDINAL HEALTHCardinal Health 200, LLCJWX2016-09-15
20885380020237CARDINAL HEALTHCardinal Health 200, LLCJWX2016-09-15
00816057020065ASI Staphslide TestARLINGTON SCIENTIFIC, INC.JWX2016-07-08
00816057020072ASI Staphslide TestARLINGTON SCIENTIFIC, INC.JWX2016-07-08
00816057020089ASI Staphslide TestARLINGTON SCIENTIFIC, INC.JWX2016-07-08
00816057020096ASI Staphslide TestARLINGTON SCIENTIFIC, INC.JWX2016-07-08
00816057020102ASI Staphslide TestARLINGTON SCIENTIFIC, INC.JWX2016-07-08
00816057020119ASI Staphslide TestARLINGTON SCIENTIFIC, INC.JWX2016-07-08
00816057021581ASI Staphslide Control SetARLINGTON SCIENTIFIC, INC.JWX2016-07-08