FDA.report

Haemophilus influenza B IgG ELISA

Primary DI
00404847425307
Brand
Haemophilus influenza B IgG ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
N/A
Catalog number
EIA-2530
Device description
Enzyme immunoassay for the determination of IgG antibodies against polyribosylribitolphosphate (PRP) of Haemophilus influenzae type B in human serum and plasma.
Published
2019-06-06
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
true

Related Records

Contact Domains

Product Codes

CodeName
GRPANTISERA, ALL TYPES, H. INFLUENZA

Product Code Classifications

CodeDeviceSpecialtyClass
GRPAntisera, All Types, H. InfluenzaMicrobiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00404847425307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00404847425307004048474253074048474253070404847425307

GMDN Terms

TermDefinition
Haemophilus influenzae culture isolate antigen IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple strains of Haemophilus influenzae bacteria isolated by culture from a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(973)564-7555corp@drg-international.com

Regulatory Flags

DUNS number
317134468
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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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