FDA.report

INSM1 (SP493) Rabbit Monoclonal Primary Antibody

Primary DI
07613336228340
Brand
INSM1 (SP493) Rabbit Monoclonal Primary Antibody
Company
Ventana Medical Systems, Inc.
Model
10161949001
Catalog number
10161949001
Published
2025-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS

Product Code Classifications

CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613336228340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613336228340076133362283407613336228340

GMDN Terms

TermDefinition
Insulinoma-associated protein 1 (INSM1) IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of insulinoma-associated protein 1 (INSM1) in a clinical specimen.

Sterilization Methods

Method

Regulatory Flags

DUNS number
184042521
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
true
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

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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

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