FDA.report

ASSY,Reag.Disp.Card,PrepKit 56,BenchMark

Primary DI
07613336128312
Brand
ASSY,Reag.Disp.Card,PrepKit 56,BenchMark
Company
Ventana Medical Systems, Inc.
Model
05253730001
Catalog number
05253730001
Published
2025-07-07
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
false

Related Records

Product Codes

CodeName
JRCMICRO PIPETTE

Product Code Classifications

CodeDeviceSpecialtyClass
JRCMicro PipetteClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613336128312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613336128312076133361283127613336128312

GMDN Terms

TermDefinition
Assay container IVD, single-useA reservoir (e.g., bottle, tube, cup) intended to be used to contain volumes of reagent, buffers, biological specimens, or other materials in preparation for in vitro diagnostic testing procedures performed in the laboratory. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
184042521
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
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 DIBrandModelCatalogPublished
07613336240281ASSY RGT DSPNR CARD BMK PREP KIT 30110637412001106374120012026-03-20
07613336240298ASSY RGT DSPNR CARD BMK PREP KIT 30210637439001106374390012026-03-20
07613336240304ASSY RGT DSPNR CARD BMK PREP KIT 30310637447001106374470012026-03-20
07613336240311ASSY RGT DSPNR CARD BMK PREP KIT 30410637455001106374550012026-03-20
07613336240328ASSY RGT DSPNR CARD BMK PREP KIT 30510637463001106374630012026-03-20
07613336240335ASSY RGT DSPNR CARD BMK PREP KIT 30610637471001106374710012026-03-20
07613336240342ASSY RGT DSPNR CARD BMK PREP KIT 30710637480001106374800012026-03-20
07613336240359ASSY RGT DSPNR CARD BMK PREP KIT 30810637498001106374980012026-03-20
07613336240366ASSY RGT DSPNR CARD BMK PREP KIT 30910637501001106375010012026-03-20
07613336240373ASSY RGT DSPNR CARD BMK PREP KIT 31010637536001106375360012026-03-20
07613336240380ASSY RGT DSPNR CARD BMK PREP KIT 31110637544001106375440012026-03-20
07613336240397ASSY RGT DSPNR CARD BMK PREP KIT 31210637552001106375520012026-03-20
07613336240403ASSY RGT DSPNR CARD BMK PREP KIT 31310637579001106375790012026-03-20
07613336240410ASSY RGT DSPNR CARD BMK PREP KIT 31410637587001106375870012026-03-20
07613336240427ASSY RGT DSPNR CARD BMK PREP KIT 31510637595001106375950012026-03-20
07613336240434ASSY RGT DSPNR CARD BMK PREP KIT 31610637609001106376090012026-03-20
07613336240441ASSY RGT DSPNR CARD BMK PREP KIT 31710637617001106376170012026-03-20
07613336240458ASSY RGT DSPNR CARD BMK PREP KIT 31810637625001106376250012026-03-20
07613336240465ASSY RGT DSPNR CARD BMK PREP KIT 31910637633001106376330012026-03-20
07613336240472ASSY RGT DSPNR CARD BMK PREP KIT 32010637641001106376410012026-03-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07613336240281ASSY RGT DSPNR CARD BMK PREP KIT 301Ventana Medical Systems, Inc.JRC2026-03-20
07613336240298ASSY RGT DSPNR CARD BMK PREP KIT 302Ventana Medical Systems, Inc.JRC2026-03-20
07613336240304ASSY RGT DSPNR CARD BMK PREP KIT 303Ventana Medical Systems, Inc.JRC2026-03-20
07613336240311ASSY RGT DSPNR CARD BMK PREP KIT 304Ventana Medical Systems, Inc.JRC2026-03-20
07613336240328ASSY RGT DSPNR CARD BMK PREP KIT 305Ventana Medical Systems, Inc.JRC2026-03-20
07613336240335ASSY RGT DSPNR CARD BMK PREP KIT 306Ventana Medical Systems, Inc.JRC2026-03-20
07613336240342ASSY RGT DSPNR CARD BMK PREP KIT 307Ventana Medical Systems, Inc.JRC2026-03-20
07613336240359ASSY RGT DSPNR CARD BMK PREP KIT 308Ventana Medical Systems, Inc.JRC2026-03-20
07613336240366ASSY RGT DSPNR CARD BMK PREP KIT 309Ventana Medical Systems, Inc.JRC2026-03-20
07613336240373ASSY RGT DSPNR CARD BMK PREP KIT 310Ventana Medical Systems, Inc.JRC2026-03-20
07613336240380ASSY RGT DSPNR CARD BMK PREP KIT 311Ventana Medical Systems, Inc.JRC2026-03-20
07613336240397ASSY RGT DSPNR CARD BMK PREP KIT 312Ventana Medical Systems, Inc.JRC2026-03-20
07613336240403ASSY RGT DSPNR CARD BMK PREP KIT 313Ventana Medical Systems, Inc.JRC2026-03-20
07613336240410ASSY RGT DSPNR CARD BMK PREP KIT 314Ventana Medical Systems, Inc.JRC2026-03-20
07613336240427ASSY RGT DSPNR CARD BMK PREP KIT 315Ventana Medical Systems, Inc.JRC2026-03-20
07613336240434ASSY RGT DSPNR CARD BMK PREP KIT 316Ventana Medical Systems, Inc.JRC2026-03-20
07613336240441ASSY RGT DSPNR CARD BMK PREP KIT 317Ventana Medical Systems, Inc.JRC2026-03-20
07613336240458ASSY RGT DSPNR CARD BMK PREP KIT 318Ventana Medical Systems, Inc.JRC2026-03-20
07613336240465ASSY RGT DSPNR CARD BMK PREP KIT 319Ventana Medical Systems, Inc.JRC2026-03-20
07613336240472ASSY RGT DSPNR CARD BMK PREP KIT 320Ventana Medical Systems, Inc.JRC2026-03-20
07613336240489ASSY RGT DSPNR CARD BMK PREP KIT 321Ventana Medical Systems, Inc.JRC2026-03-20
07613336240496ASSY RGT DSPNR CARD BMK PREP KIT 322Ventana Medical Systems, Inc.JRC2026-03-20
07613336240502ASSY RGT DSPNR CARD BMK PREP KIT 323Ventana Medical Systems, Inc.JRC2026-03-20
07613336240519ASSY RGT DSPNR CARD BMK PREP KIT 324Ventana Medical Systems, Inc.JRC2026-03-20
07613336240526ASSY RGT DSPNR CARD BMK PREP KIT 325Ventana Medical Systems, Inc.JRC2026-03-20
07613336221204ASSY RGT DSPNR CARD BMK PREP KIT 551Ventana Medical Systems, Inc.JRC2025-12-15
07613336221211ASSY RGT DSPNR CARD BMK PREP KIT 552Ventana Medical Systems, Inc.JRC2025-12-15
07613336221228ASSY RGT DSPNR CARD BMK PREP KIT 553Ventana Medical Systems, Inc.JRC2025-12-15
07613336221235ASSY RGT DSPNR CARD BMK PREP KIT 554Ventana Medical Systems, Inc.JRC2025-12-15
07613336221242ASSY RGT DSPNR CARD BMK PREP KIT 555Ventana Medical Systems, Inc.JRC2025-12-15