FDA.report

Opti-MEM® I Reduced-Serum Medium

Primary DI
30190302004309
Brand
Opti-MEM® I Reduced-Serum Medium
Company
LIFE TECHNOLOGIES CORPORATION
Model
31985070
Published
2016-08-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Related Records

Product Codes

CodeName
KITMEDIA AND COMPONENTS, SYNTHETIC CELL AND TISSUE CULTURE

Product Code Classifications

CodeDeviceSpecialtyClass
KITMedia And Components, Synthetic Cell And Tissue CultureHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30190302004309PackageGS110Not in Commercial Distribution
10190302004305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3019030200430930190302004309
1019030200430510190302004305

GMDN Terms

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

Regulatory Flags

DUNS number
118793157
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 DIBrandModelCatalogPublished
10190302018982TaqPath™ COVID-19, Flu A, Flu B, RSV Select AssayA564402025-02-17
10190302018999TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive Control9636122025-02-17
10190302019002TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control9636092025-02-17
10190302019019TaqPath™ 1-Step Select Master Mix (No ROX)A56518A561232025-02-17
10190302019026TaqPath™ COVID-19, Flu A, Flu B, RSV Select AssayA564412025-02-17
10190302019033TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive Control9636132025-02-17
10190302019040TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control9636082025-02-17
10190302019057TaqPath™ 1-Step Select Master Mix (No ROX)A565192025-02-17
10190302019422Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Assay KitA572972025-02-17
80190302019438Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution BufferA577402025-02-17
10190302019446Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control9661362025-02-17
10190302006385Oncomine™ Dx Target TestA324412017-06-27
10190302005197Aim -V™ MediumA18398DJ2016-08-01
10190302012041Human CD99 FITC ConjugateMHCD99012018-06-15
10190302012058Human CD99 R-PE ConjugateMHCD99042018-06-15
10190302012065Human CXCR4 (CD184) R-PE ConjugateMHCXCR4042018-06-15
10190302012164Anti-Human HLA-DR (Class II) FITC ConjugateMHLDR012018-06-15
10190302012171Anti-Human HLA-DR (Class II) R-PE ConjugateMHLDR042018-06-15
10190302012188Anti-Human HLA-DR (Class II) APC ConjugateMHLDR052018-06-15
10190302012195Anti-Human HLA-DR (Class II) PE-Texas Red® ConjugateMHLDR172018-06-15

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840075404682CHO Feed Base BLonza Walkersville, Inc.KIT2026-03-05
00840075404699CHO Feed Base BLonza Walkersville, Inc.KIT2026-03-05
00840075404651CHO Feed Base FLonza Walkersville, Inc.KIT2026-02-26
00840075404668CHO Feed Base FLonza Walkersville, Inc.KIT2026-02-26
00840075404675CHO Feed Base FLonza Walkersville, Inc.KIT2026-02-26
00840075404644X-VIVO 15 without Phenol Red and Gentamicin contains Recombinant TransferrinLonza Walkersville, Inc.KIT2026-02-09
05407010129823Custom M199 w/o PR w/U1, Pluronic-4L bagLonza VerviersKIT2025-12-23
05407010129830Custom M199 w/o PR w/U1, Pluronic-1L BotLonza VerviersKIT2025-12-23
05407010129694PBS - 1L Bag- SampleLonza VerviersKIT2025-12-16
05407010129687PBS - 1L- SampleLonza VerviersKIT2025-12-15
00840075404583GLS CHO Feed FLonza Walkersville, Inc.KIT2025-12-03
00840075404590GLS CHO Feed FLonza Walkersville, Inc.KIT2025-12-03
00840075404606GLS CHO Feed FLonza Walkersville, Inc.KIT2025-12-03
00840075404613GLS CHO Feed FLonza Walkersville, Inc.KIT2025-12-03
00840075404620GLS CHO Feed FLonza Walkersville, Inc.KIT2025-12-03
00840075404637GLS CHO Feed FLonza Walkersville, Inc.KIT2025-12-03
05407010129656CD CHO Medium AGT-200Lbag filled to 100LLonza VerviersKIT2025-11-13
05407010128994DMEM Glutamax 2% SRPT - 500ml bag SAMPLE Lonza VerviersKIT2025-09-29
05407010128659 ProCHO5 w/Pluro w/o L-Gln or HT 0.5LLonza VerviersKIT2025-09-15
05407010128789ProDoma 3 (KF10) w/o L-Glutamine 20L baLonza VerviersKIT2025-09-15
00840075404521CHO Feed Base LLonza Walkersville, Inc.KIT2025-09-12
00840075404538TheraPRO CHO Expansion MediumLonza Walkersville, Inc.KIT2025-09-12
05407010128499ModProCHO5 w/8mM L-Gln,0.25% Pluro 500mLLonza VerviersKIT2025-08-20
05407010128536CD CHO Medium AGT - 20L bagLonza VerviersKIT2025-08-20
05407010128543CD CHO Medium AGT - 100L Flexsafe bagLonza VerviersKIT2025-08-20
05407010128550CD CHO Medium AGT - 1L bottleLonza VerviersKIT2025-08-20
05407010128567DMEM Glutamax 2% SRPT - 50L bagLonza VerviersKIT2025-08-20
05407010128574DMEM Glutamax 2% SRPT - 1L bottleLonza VerviersKIT2025-08-20
05407010128581Sky FM03 - 1L bottleLonza VerviersKIT2025-08-20
05407010128598X-Vivo 20 w/o Genta, PR w/ U1,OptiferrinLonza VerviersKIT2025-08-20