FDA.report

Pneumococcus Anti CWPS high titer, 1 mL

Primary DI
05713106913048
Brand
Pneumococcus Anti CWPS high titer, 1 mL
Company
Ssi Diagnostica A/S
Model
91304
Catalog number
91304
Device description
Rabbit antiserum, High titer
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
05713106913048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05713106913048057131069130485713106913048

GMDN Terms

TermDefinition
Streptococcus pneumoniae total antibody IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of total antibodies to Streptococcus pneumoniae bacteria in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 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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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