FDA.reportPublic FDA data

Alinity m

Primary DI
00884999050280
Brand
Alinity m
Company
ABBOTT MOLECULAR INC.
Model
09N92-010
Catalog number
09N92-010
Device description
Abbott Bulk Universal Collection Kit
Published
2022-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QJRReagents, 2019-novel coronavirus nucleic acid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJRReagents, 2019-Novel Coronavirus Nucleic AcidUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884999050280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884999050280008849990502808849990502800884999050280

GMDN Terms#

Term, Definition table
TermDefinition
General specimen collection kit IVD, clinicalA collection of in vitro diagnostic devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered specimen receptacle with or without an additive/medium (e.g., preservation solution, microbiological medium). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)553-7042customerservice@abbottmolecular.com

Regulatory Flags#

DUNS number
878263359
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884999051287Alinity m09N15-03B09N15-03B2026-04-13
00884999051690simpli-COLLECT09R16-00109R16-0012026-04-13
00884999052062Alinity m09N61-03B09N61-03B2025-11-20
00884999047846Alinity m09N26-00109N26-0012020-04-29
00884999047853Alinity m09N26-00209N26-0022020-04-29
00884999047860Alinity m09N26-01009N26-0102020-04-29
00884999047426Alinity m09N26-01209N26-0122020-04-29
00884999047440Alinity m09N26-01409N26-0142020-04-29
00884999047464Alinity m09N26-01609N26-0162020-04-29
00884999047501Alinity m09N26-00409N26-0042020-04-29
00884999048096Alinity m09N26-01909N26-0192020-04-29
00884999048171Alinity m09N26-02009N26-0202020-04-29
00884999048034Alinity m08N53-00208N53-0022020-08-18
00884999031814m20009K15-019K15-012016-09-01
00884999049369Alinity m09N79-09509N79-0952025-06-27
00884999049376Alinity m09N79-08509N79-0852025-06-27
00884999049383Alinity m09N79-03A09N79-03A2025-06-27
00884999051348simpli-COLLECT09R02-00109R02-0012025-06-26
00884999051409simpli-COLLECT09N93-00109N93-0012025-06-26
30884999051349simpli-COLLECT09R02-00109R02-0012025-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810096640093Biomeme SARS-CoV-2 Go-PlatesBiomeme, Inc.QJR2022-12-02
00810096640109Biomeme DNA/RNA Preservation Buffer (100/pk)Biomeme, Inc.QJR2022-12-02
00810096640017Biomeme Franklin three9 Real-Time PCR ThermocyclerBiomeme, Inc.QJR2022-12-02
00810096640024Biomeme Franklin three9 Real-Time PCR ThermocyclerBiomeme, Inc.QJR2022-12-02
10810096640038Biomeme M1 Sample Prep Cartridge Kit for RNA 2.0Biomeme, Inc.QJR2022-12-02
10810096640045Biomeme SARS-CoV-2 Go-Strips KitBiomeme, Inc.QJR2022-12-02
10810096640052Biomeme SARS-CoV-2 Go-StripsBiomeme, Inc.QJR2022-12-02
10810096640069Biomeme Void Filling CapsBiomeme, Inc.QJR2022-12-02
10810096640076Biomeme RNA Process Control (RPC) KiitBiomeme, Inc.QJR2022-12-02
10810096640083Biomeme SARS-CoV-2 Go-Plates KitBiomeme, Inc.QJR2022-12-02
10810096640090Biomeme SARS-CoV-2 Go-PlatesBiomeme, Inc.QJR2022-12-02
10810096640106Biomeme DNA/RNA Preservation Buffer (100/pk)Biomeme, Inc.QJR2022-12-02
00810096640116Biomeme Franklin three9 Real-Time PCR ThermocyclerBiomeme, Inc.QJR2022-12-02
00810096640123Biomeme Franklin three9 Real-Time PCR ThermocyclerBiomeme, Inc.QJR2022-12-02
00810096640130Biomeme GoDx App for USBiomeme, Inc.QJR2022-12-02
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