FDA.reportPublic FDA data

VITEK® 2 ANC

Primary DI
03573026144364
Brand
VITEK® 2 ANC
Company
BIOMERIEUX , INC.
Model
VITEK® 2 ANC
Device description
The VITEK® 2 ANC Identification Card is intended for use with the VITEK 2 Systems for ID of clinically important anaerobic bacteria and coryneform bacteria
Published
2020-06-02
Public version status
Update
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
JSPKIT, ANAEROBIC IDENTIFICATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSPKit, Anaerobic IdentificationMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026144364PackageGS120In Commercial Distribution
03573026529727PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026144364035730261443643573026144364
03573026529727035730265297273573026529727

GMDN Terms#

Term, Definition table
TermDefinition
Multiple anaerobic 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 anaerobic bacteria isolated by culture from a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
086785110
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
03573026628116VITEK® 2 AST-XN19VITEK® 2 AST-XN192022-04-15
03573026618285VITEK10.02025-05-15
03573026612047BACT/ALERT® BPABACT/ALERT® BPA2020-06-26
03573026614157BACT/ALERT® BPNBACT/ALERT® BPN2020-06-26
03573026613914VITEK® 2 Knowledge base update 09.039.032022-04-11
03573026615499VITEK® COMPACT PRO4234652025-05-15
03573026222222VITEK® 2 DENSICHEK® Plus Standards Kit212552016-11-30
03573026609399VITEK® 2 Software 09.029.02.02019-06-12
03573026530808VITEK® 2 AST-GP74VITEK® 2 AST-GP742017-01-09
03573026595722BACT/ALERT® PFBACT/ALERT® PF2020-04-22
03573026595906BACT/ALERT® FABACT/ALERT® FA2020-04-23
03573026595920BACT/ALERT® FNBACT/ALERT® FN2020-04-23
03573026222239DENSICHEK® Plus212502016-11-30
03573026530914VITEK® 2 AST-GN68VITEK® 2 AST-GN682017-01-09
03573026647780VITEK® 2 AST-N816VITEK® 2 AST-N8162025-11-21
03573026638887VITEK® REVEAL™ BC GN02-ASTVITEK® REVEAL™ BC GN02-AST2024-10-09
03573026613112PREVI™ Isola Applicator CartrigePREVI™ Isola Applicator Cartrige2020-06-26
03573026145842VITEK®227222R2016-09-14
03573026553968VITEK®28.012017-01-03
03573026619060VITEK®29.01.12019-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590657352MicroScanBeckman Coulter, Inc.JSP2022-12-05
05032384028528PET RPLA KITOXOID LIMITEDJSP2022-12-04
15099590655907MicroScanBeckman Coulter, Inc.JSP2022-11-15
15099590655983MicroScanBeckman Coulter, Inc.JSP2022-11-15
00848838058035Remel REMEL, INC.JSP2021-11-12
30848838058036Remel REMEL, INC.JSP2021-11-12
03848838058032Remel REMEL, INC.JSP2021-11-12
03573026529727VITEK® 2 ANCBIOMERIEUX , INC.JSP2020-06-02
03573026588564RAPID ID 32 ABIOMERIEUX SAJSP2020-04-10
03573026048150API® 20 ABIOMERIEUX SAJSP2020-04-10
03573026066420rapid ID 32 ABIOMERIEUX SAJSP2020-04-10
30382902450109BD BBL™ Crystal™ ANRBECTON, DICKINSON AND COMPANYJSP2018-05-25
30382902450383BD BBL™ Crystal™ ANR, GP, RGP, N/H ID Inoculum FluidBECTON, DICKINSON AND COMPANYJSP2018-05-25
00382902450115BD BBL™ Crystal™ ID Systems Anaerobe Manual CodebookBECTON, DICKINSON AND COMPANYJSP2018-05-25