FDA.report

S. pneumoniae reference strain 12F

Primary DI
05713106822012
Brand
S. pneumoniae reference strain 12F
Company
Ssi Diagnostica A/S
Model
82201
Catalog number
82201
Device description
Reference strain
Published
2021-08-01
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
true

Related Records

Contact Domains

Product Codes

CodeName
GTYANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

Product Code Classifications

CodeDeviceSpecialtyClass
GTYAntigens, All Groups, Streptococcus Spp.Microbiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05713106822012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05713106822012057131068220125713106822012

GMDN Terms

TermDefinition
Streptococcus pneumoniae culture isolate antigen IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative detection of antigens from Streptococcus pneumoniae bacteria isolated by culture from a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature8 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+4548299100info@ssidiagnostica.com

Regulatory Flags

DUNS number
305684449
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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05713106544013E. coli H4 serum, 5 mL54401544012021-08-11
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05713106544129E. coli H11 serum, 5 mL54412544122021-08-11
05713106544143E. coli H12 serum, 5 mL54414544142021-08-11
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05713106544174E. coli H15 serum, 5 mL54417544172021-08-11
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05713106544228E. coli H18 serum, 5 mL54422544222021-08-11
05713106544242E. coli H19 serum, 5 mL54424544242021-08-11
05713106544259E. coli H20 serum, 5 mL54425544252021-08-11
05713106544266E. coli H21 serum, 5 mL54426544262021-08-11
05713106544273E. coli H23 serum, 5 mL54427544272021-08-11

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05713106821756S. pneumoniae reference strain 1Ssi Diagnostica A/SGTY2021-08-01
05713106821763S. pneumoniae reference strain 2Ssi Diagnostica A/SGTY2021-08-01
05713106821770S. pneumoniae reference strain 3Ssi Diagnostica A/SGTY2021-08-01
05713106821787S. pneumoniae reference strain 4Ssi Diagnostica A/SGTY2021-08-01
05713106821794S. pneumoniae reference strain 5Ssi Diagnostica A/SGTY2021-08-01
05713106821800S. pneumoniae reference strain 6ASsi Diagnostica A/SGTY2021-08-01
05713106821817S. pneumoniae reference strain 6BSsi Diagnostica A/SGTY2021-08-01
05713106821824S. pneumoniae reference strain 6CSsi Diagnostica A/SGTY2021-08-01
05713106821831S. pneumoniae reference strain 7FSsi Diagnostica A/SGTY2021-08-01
05713106821848S. pneumoniae reference strain 7ASsi Diagnostica A/SGTY2021-08-01
05713106821855S. pneumoniae reference strain 7BSsi Diagnostica A/SGTY2021-08-01
05713106821862S. pneumoniae reference strain 7CSsi Diagnostica A/SGTY2021-08-01
05713106821879S. pneumoniae reference strain 8Ssi Diagnostica A/SGTY2021-08-01
05713106821886S. pneumoniae reference strain 9ASsi Diagnostica A/SGTY2021-08-01
05713106821893S. pneumoniae reference strain 9LSsi Diagnostica A/SGTY2021-08-01
05713106821909S. pneumoniae reference strain 9NSsi Diagnostica A/SGTY2021-08-01