FDA.report

MGB Alert® Chlamydophila Pneumoniae Primer Mix ASR - 48 Reactions

Primary DI
03661540951763
Brand
MGB Alert® Chlamydophila Pneumoniae Primer Mix ASR - 48 Reactions
Company
ELITECH GROUP INC.
Model
800433
Catalog number
800433
Device description
"MGB Alert® Chlamydophila pneumoniae Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Chlamydophila pneumoniae . The mix consists of a total of 7.20 nmol of primers per vial in a 1X TE buffer solution. The primers amplify an 80 bp nucleic acid sequence from the Major Outer Membrane Protein gene region of Chlamydophila pneumoniae."
Published
2020-09-08
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
false

Related Records

Contact Domains

Product Codes

CodeName
MVUReagents, Specific, Analyte

Product Code Classifications

CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03661540951763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03661540951763036615409517633661540951763

GMDN Terms

TermDefinition
Chlamydia pneumoniae 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 Chlamydia pneumoniae bacteria in a clinical specimen, using a nucleic acid technique (NAT).

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-10 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
8004532725mdx@elitechgroup.com

Regulatory Flags

DUNS number
079696864
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
true
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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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
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
03661540952272MGB Alert® BKV Primer Mix ASR - 480 Reactions QTY 25800332-25800332-252022-04-04
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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
03661540950032MGB Alert Internal Control Set IC2-BH 48 rxnM800574M8005742020-09-15
03661540950124MGB Alert Internal Control Set IC2-B, 09N38-001800430-am800430-am2020-09-15
03661540950155MGB Alert Internal Control Set IC1, 09N39-001800427-am800427-am2020-09-15
03661540950186MGB Alert Internal Control Set IC1-A, 09N40-001800495-am800495-am2020-09-15
03661540950247MGB Alert Internal Control Set IC2-TM800580M8005802020-09-15
03661540950254MGB Alert Internal Control Set IC2-T, 09N42-001M800580-amM800580-am2020-09-15
03661540950278MGB Alert Platinum Master Mix-48 rxnM800599M8005992020-09-15

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