FDA.reportPublic FDA data

AIM-V Medium

Primary DI
05051716000162
Brand
AIM-V Medium
Company
Oxford Immunotec, Inc.
Model
AV.200/50
Catalog number
AV.200/50
Device description
AIM-V® serum free cell culture medium is intended for use in the preparation of peripheral blood mononuclear cells (PBMCs) from whole blood and for use as a culture medium for in vitro testing using the ELISPOT method. PBMCs, separated from whole blood samples, are washed with AIM-V medium and the cell pellet is re-suspended in the medium. The cells are counted using a haemocytometer or automated cell counter before being diluted to the required concentration in AIM-V.
Published
2023-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KZICulture Media, Enriched

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZICulture Media, EnrichedMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051716000162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051716000162050517160001625051716000162

GMDN Terms#

Term, Definition table
TermDefinition
Cell culture medium IVDA liquid based tissue culture medium containing essential nutrients, sugars, amino acids and growth factors, intended to be used for the in-vitro maintenance, sustenance, and cultivation of human cells from a clinical specimen for diagnostic purposes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
009744265
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051716000131T-Cell Select®TSK.960TSK.9602026-01-15
05051716000544Leucosep TubesLTK.615 USLTK.615 US2023-03-31
05051716000087Leucosep TubesLTK.615LTK.6152023-02-07
05051716000155AIM-V MediumAV.200/500AV.200/5002023-02-07
05051716000186T-Cell Select®TSK.910TSK.910US2023-02-07
15051716000008T-SPOT®.TB96TB.200TB.200US2015-09-15
15051716000022T.Cell Xtend®TTK.610TTK.610US2014-08-12
15051716000046T-SPOT®.TB50TB.50TB.50US2014-08-12
15051716000053T.Cell Xtend®TTK.650TTK.650US2014-08-12
15051716000305T-SPOT®.TB8TB.300TB.300US2014-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10382902218088BD BBL™ BCYE AgarBECTON, DICKINSON AND COMPANYKZI2024-09-19
30382902218082BD BBL™ BCYE AgarBECTON, DICKINSON AND COMPANYKZI2024-09-19
00850056467063Schaedler Blood Agar OxyPlateOxyrase, Inc.KZI2023-11-30
00810144911120RediporAnalytiChem USA, Inc.KZI2023-09-21
00810144911144RediporAnalytiChem USA, Inc.KZI2023-09-21
00810144911151RediporAnalytiChem USA, Inc.KZI2023-09-21
05051716000155AIM-V MediumOxford Immunotec, Inc.KZI2023-02-07
00848838001505REMELREMEL, INC.KZI2023-01-04
00848838010965REMELREMEL, INC.KZI2023-01-04
00848838010972REMELREMEL, INC.KZI2023-01-04
00848838012136REMELREMEL, INC.KZI2023-01-04
00848838012174REMELREMEL, INC.KZI2023-01-04
00819398020565N/AHARDY DIAGNOSTICSKZI2022-07-25
00819398020558N/AHARDY DIAGNOSTICSKZI2022-07-25
00819398028431N/AHARDY DIAGNOSTICSKZI2020-09-02
00816576027576N/AHARDY DIAGNOSTICSKZI2020-06-08
00816576027613N/AHARDY DIAGNOSTICSKZI2020-06-08
00819398024228HardyFlask™HARDY DIAGNOSTICSKZI2020-06-08
00819398024242HardyFlask™HARDY DIAGNOSTICSKZI2020-06-08
00819398024266HardyFlask™HARDY DIAGNOSTICSKZI2020-06-08
00819398024235HardyFlask™HARDY DIAGNOSTICSKZI2020-06-08
00816576027262N/AHARDY DIAGNOSTICSKZI2020-06-05
00816576027477N/AHARDY DIAGNOSTICSKZI2020-06-05
00819398023535N/AHARDY DIAGNOSTICSKZI2020-06-05
00819398023528N/AHARDY DIAGNOSTICSKZI2020-06-05
00819398022194N/AHARDY DIAGNOSTICSKZI2020-06-03
00819398022293N/AHARDY DIAGNOSTICSKZI2020-06-03
00819398028127N/AHARDY DIAGNOSTICSKZI2020-06-03
00819398022187N/AHARDY DIAGNOSTICSKZI2020-06-03
00819398022286N/AHARDY DIAGNOSTICSKZI2020-06-03