FDA.report

Copy Control 12 Aqua

Primary DI
00847627000552
Brand
Copy Control 12 Aqua
Company
BIOCARE MEDICAL LLC
Model
PFA7211V
Published
2022-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
MVUReagents, Specific, Analyte

Product Code Classifications

CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00847627000552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847627000552008476270005528476270005520847627000552

GMDN Terms

TermDefinition
Nucleic acid hybridization detection IVD, probeA defined piece(s) of nucleic acid, typically tagged with a fluorescent marker, intended to be used for the detection of a specific target nucleotide sequence at a single-gene locus or whole/partial chromosome level in a clinical specimen, in order to identify chromosomal abnormalities (e.g., aneuploidy, deletion, translocation, duplication, inversion, gene insertion). It is typically used in nucleic acid hybridization detection techniques [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH)].

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-20 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
806617825
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

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