FDA.reportPublic FDA data

MGB Alert® CMV 3.0 Primer Mix ASR - 480 Reactions QTY-25

Primary DI
03661540952197
Brand
MGB Alert® CMV 3.0 Primer Mix ASR - 480 Reactions QTY-25
Company
ELITECH GROUP INC.
Model
800350-25
Catalog number
800350-25
Device description
MGB Alert® CMV 3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from the IE1 region of CMV (Cytomegalovirus). QTY-25@ 480reactions.
Published
2022-04-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MVUReagents, Specific, Analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661540952197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540952197036615409521973661540952197

GMDN Terms#

Term, Definition table
TermDefinition
Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from cytomegalovirus (CMV) in a clinical specimen, using a nucleic acid technique (NAT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-10 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079696864
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661540952371MGB Alert IC1 Internal Control Template (35uL volume)M8007352022-07-05
03661540952258MGB Alert Internal Control Set IC2-B, 480 rxn QTY-25800363-25800363-252022-04-04
03661540952265MGB Alert Internal Control Set IC2-B, 480 rxn QTY-100800363-100800363-1002022-04-04
03661540952296 MGB Alert Internal Control Set IC2-C -480 rxn QTY-25800432-25800432-252022-04-04
03661540952302 MGB Alert Internal Control Set IC2-C -480 rxn QTY-100800432-100800432-1002022-04-04
03661540952173MGB Alert® BKV Primer Mix ASR - 480 Reactions QTY 100800332-100800332-1002022-04-04
03661540952180MGB Alert® BKV Probe Mix ASR - 480 Reactions QTY-100800333-100800333-1002022-04-04
03661540952203MGB Alert® CMV 3.0 Primer Mix ASR - 480 Reactions QTY-100800350-100800350-1002022-04-04
03661540952210MGB Alert® CMV 3.0 Probe Mix ASR - 480 Reactions QTY-25800404-25800404-252022-04-04
03661540952227MGB Alert® CMV 3.0 Probe Mix ASR - 480 Reactions QTY-100800404-100800404-1002022-04-04
03661540952272MGB Alert® BKV Primer Mix ASR - 480 Reactions QTY 25800332-25800332-252022-04-04
03661540952289MGB Alert® BKV Probe Mix ASR - 480 Reactions QTY-25800333-25800333-252022-04-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810034703170PerCP anti-human CD61BIOLEGEND, INC.MVU2026-08-07
03661540953170DSQ Alert HT Adenovirus Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953187DSQ Alert HT Adenovirus Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953217DSQ Alert Hepatitis E Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953224DSQ Alert Hepatitis E Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953279DSQ Alert Mycoplasma pneumoniae Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953286DSQ Alert Mycoplasma pneumoniae Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
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00810034704320PE anti-human IL-2BIOLEGEND, INC.MVU2026-07-28
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00810227730150Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730228Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
05055844935792CytoCell myProbesCYTOCELL LIMITEDMVU2026-07-19