FDA.report

Stemphylium botryosum

Primary DI
00816879021592
Brand
Stemphylium botryosum
Company
HYCOR BIOMEDICAL LLC
Model
M010
Catalog number
74390
Device description
A 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 an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.
Published
2016-09-26
Public version status
Update
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
DHBSystem, Test, Radioallergosorbent (Rast) Immunological

Product Code Classifications

CodeDeviceSpecialtyClass
DHBSystem, Test, Radioallergosorbent (Rast) ImmunologicalImmunology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816879021592PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816879021592008168790215928168790215920816879021592

GMDN Terms

TermDefinition
Allergen-specific immunoglobulin E (IgE) 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 an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
800-382-2527Customerservices-us@hycorbiomedical.com

Regulatory Flags

DUNS number
010558476
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
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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Primary DIBrandCompanyProduct codePublished
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00810053950371NOVEOS Clam, Mercenaria mercenariaHYCOR BIOMEDICAL LLCDHB2026-01-20
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00810053950500NOVEOS German Cockroach, Blatella germanicaHYCOR BIOMEDICAL LLCDHB2026-01-20
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